Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

NCT06145308 | Recruiting Phase 2

• 1 other identifier: NCC4132
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.

Conditions

Salivary Gland Carcinoma; Precision Therapy

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR rates for neoadjuvant and translational therapy in patients with locally advanced/recurrent and advanced oligometastatic salivary gland cancer and ORR rate of salvage therapy for locally advanced/recurrent or distantly metastatic salivary gland carcinoma with rapid progression that cannot tolerate or refuses surgery

  ORR at the end of Cycle 2 (each cycle is 21 days)

Secondary Outcomes (6)

• MPR;

  MPR rate at the end of surgical treatment

• R0 resection rate;

  R0 resection rate at the end of surgical treatment

• Facial nerve protection rate

  Facial nerve protection rate at the end of surgical treatment

• DFS

  DFS rates at 3-year

• PFS;

  PFS Rate at 2-Year

Study Arms (20)

Cohort 1 (HER2-positive, RC48-ADC)

EXPERIMENTAL

Disitamab vedotin 2.5 mg/kg will be administered as an intravenous infusion every 2 weeks (Q2W) as monotherapy, or in combination with physician-selected platinum-based chemotherapy (carboplatin 200-250 mg/m² IV Q2W or cisplatin 50 mg/m² IV Q2W).

Drug: Cohort 1 (HER2-positive, RC48-ADC)

Cohort 2 (NTRK-fusion or NTRK-mutant)

EXPERIMENTAL

larotrectinib 100 mg orally twice daily or entrectinib 600 mg orally once daily;

Drug: Cohort 2 (NTRK-fusion or NTRK-mutant)

Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)

EXPERIMENTAL

leuprolide 3.75 mg subcutaneously every 4 weeks, bicalutamide 50 mg orally once daily, and abiraterone 1 000 mg orally once daily.

Drug: Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)

Cohort 4 (TROP2 ADC)

EXPERIMENTAL

ESG401 16 mg/kg IV (days 1, 8, 15, q4w), sacituzumab govitecan 10 mg/kg IV (days 1 \& 8, q3w), or sacituzumab tirumotecan 5 mg/kg IV q2w.

Drug: TROP2 ADC

Cohort 5 (ACC-TKI)

EXPERIMENTAL

apatinib 250 mg qd po or anlotinib 12 mg

Drug: TKI

Cohort 6 (albumin-bound paclitaxel + platinum)

EXPERIMENTAL

albumin-bound paclitaxel 260 mg/m² IV q3w plus physician-selected cisplatin 75 mg/m² IV q3w or carboplatin 350 mg/m² IV q3w.

Drug: Albumin-paclitaxel + platinum

Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab)

EXPERIMENTAL

albumin-bound paclitaxel 260 mg/m² IV q3w, carboplatin 350 mg/m² IV q3w, camrelizumab 200 mg IV q3w, and apatinib 250 mg qd po.

Drug: Albumin-paclitaxel + carboplatin + apatinib + camrelizumab

Cohort 8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib)

EXPERIMENTAL

albumin-bound paclitaxel 260 mg/m² + trastuzumab (loading 8 mg/kg → 6 mg/kg IV q3w) + pyrotinib 400 mg PO qd.

Drug: albumin-bound paclitaxel+trastuzumab+pyrotinib

Cohort 9 (HER2-positive, DS-8201 ± pertuzumab)

EXPERIMENTAL

trastuzumab deruxtecan 5.4 mg/kg IV q3w ± pertuzumab (loading 840 mg → 420 mg IV q3w).

Drug: HER2,trastuzumab deruxtecan± pertuzumab

Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab)

EXPERIMENTAL

Darolutamide 600mg po bid / Enzalutamide 160mg po qd / Apalutamide 240mg po qd / Rivarutamide 240mg po qd + goserelin 10.8 mg SC q12w + pertuzumab/trastuzumab loading 15 mL → 10 mL SC q3w.

Drug: AR,AR antagonist ++ goserelin + pertuzumab + trastuzumab

Cohort 11 (AR-positive, AR antagonist+ goserelin ± docetaxel)

EXPERIMENTAL

Darolutamide 600mg po bid / Enzalutamide 160mg po qd / Apalutamide 240mg po qd / Rivarutamide 240mg po qd+ goserelin 10.8 mg SC q12w ± docetaxel 75 mg/m² IV q3w.

Drug: AR,AR antagonist +goserelin +docetaxel

Cohort 12 (ivonescimab)

EXPERIMENTAL

ivonescimab 20 mg/kg + investigator-choice platinum doublet (albumin-paclitaxel 260 mg/m², liposomal paclitaxel 175 mg/m², docetaxel 75 mg/m², or vinorelbine 25 mg/m² d1,d8) plus cisplatin 75 mg/m² or carboplatin AUC 5-6 IV q3w.

Drug: ivonescimab + investigator-choice platinum doublet+

Cohort 13 (iparomlimab + tuvonralimab)

EXPERIMENTAL

iparomlimab 5 mg/kg + platinum doublet (as above) ± bevacizumab 5 mg/kg IV q3w.

Drug: iparomlimab + tuvonralimab

Cohort 14 (cadonilimab)

EXPERIMENTAL

cadonilimab 10 mg/kg + platinum doublet (as above) ± bevacizumab 5 mg/kg IV q3w.

Drug: cadonilimab

Cohort 15 (HR-positive)

EXPERIMENTAL

CDK4/6 inhibitor (abemaciclib 150 mg PO bid or palbociclib 125 mg PO qd) plus AI (letrozole 2.5 mg, anastrozole 1 mg, or exemestane 20 mg PO qd) or fulvestrant 500 mg IM q4w

Drug: CDK4/6 inhibitor+AI or fulvestrant

Cohort 16 (PI3K-mutant)

EXPERIMENTAL

alpelisib 300 mg PO qd plus fulvestrant 500 mg IM q4w.

Drug: alpelisib+fulvestrant

Cohort 17 (homologous-recombination-deficient)

EXPERIMENTAL

PARP inhibitor (olaparib 300 mg PO bid, niraparib 300 mg PO qd, fluzoparib 150 mg PO bid, or pamiparib 60 mg PO bid).

Drug: PARP inhibitor

Cohort 18 (Nectin-4 ADC)

EXPERIMENTAL

enfortumab vedotin 1.25 mg/kg IV d1,d8,d15 (max 125 mg) ± ICI (pembrolizumab 200 mg, camrelizumab 200 mg, or toripalimab 240 mg IV q3w).

Drug: enfortumab vedotin

Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab)

EXPERIMENTAL

pyrotinib 400 mg PO qd + pertuzumab/trastuzumab loading 15 mL → 10 mL SC q3w.

Drug: HER2, pyrotinib + pertuzumab/trastuzumab

⑳ Cohort 20 (vebecotutamab ±lenvatinib):

EXPERIMENTAL

verbecotutamab 2.0 mg/kg ivgtt ± lenvatinib 8mg qd q3w

Drug: vebecotutamab ±lenvatinib

Interventions

Cohort 1 (HER2-positive, RC48-ADC) DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: HER2,Vedolizumab

Cohort 1 (HER2-positive, RC48-ADC)

Cohort 2 (NTRK-fusion or NTRK-mutant) DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: NTRK-inhibitor

Cohort 2 (NTRK-fusion or NTRK-mutant)

Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone) DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: AR,leuprolide + bicalutamide + abiraterone

Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone)

TROP2 ADC DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 4 (TROP2 ADC)

Cohort 4 (TROP2 ADC)

TKI DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 5 (ACC-TKI)

Cohort 5 (ACC-TKI)

Albumin-paclitaxel + platinum DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 6 (albumin-bound paclitaxel + platinum)

Cohort 6 (albumin-bound paclitaxel + platinum)

Albumin-paclitaxel + carboplatin + apatinib + camrelizumab DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab)

Cohort 7 (albumin-bound paclitaxel + carboplatin + apatinib + camrelizumab)

albumin-bound paclitaxel+trastuzumab+pyrotinib DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib)

Cohort 8 (HER2-positive, albumin-bound paclitaxel + trastuzumab + pyrotinib)

HER2,trastuzumab deruxtecan± pertuzumab DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort9(HER2-positive, DS-8201 ± pertuzumab)

Cohort 9 (HER2-positive, DS-8201 ± pertuzumab)

ivonescimab + investigator-choice platinum doublet+ DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 12 (ivonescimab)

Cohort 12 (ivonescimab)

iparomlimab + tuvonralimab DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 13 (iparomlimab + tuvonralimab)

Cohort 13 (iparomlimab + tuvonralimab)

cadonilimab DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 14 (cadonilimab)

Cohort 14 (cadonilimab)

CDK4/6 inhibitor+AI or fulvestrant DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 15 (HR-positive)

Cohort 15 (HR-positive)

alpelisib+fulvestrant DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 16 (PI3K-mutant)

Cohort 16 (PI3K-mutant)

PARP inhibitor DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 17 (homologous-recombination-deficient)

Cohort 17 (homologous-recombination-deficient)

enfortumab vedotin DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 18 (Nectin-4 ADC)

Cohort 18 (Nectin-4 ADC)

HER2, pyrotinib + pertuzumab/trastuzumab DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab)

Cohort 19 (HER2-positive, pyrotinib + pertuzumab + trastuzumab)

AR,AR antagonist ++ goserelin + pertuzumab + trastuzumab DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab)

Cohort 10 (HER2+/AR+, AR antagonist + goserelin + pertuzumab + trastuzumab)

AR,AR antagonist +goserelin +docetaxel DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 11 (AR-positive, AR antagonist + goserelin ± docetaxel)

Cohort 11 (AR-positive, AR antagonist+ goserelin ± docetaxel)

vebecotutamab ±lenvatinib DRUG

Neoadjuvant / conversion phase: After 2-6 cycles of protocol therapy, patients are re-evaluated. Those deemed resectable undergo surgery of the primary tumour ± metastatic sites, followed by radiotherapy or other modalities (e.g., radiofrequency ablation) at the investigator's discretion. Patients who remain unresectable after six cycles continue the same regimen until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to stop. Adjuvant phase: Treatment is administered for 1 years, or until intolerable toxicity or withdrawal of consent. Salvage phase: Therapy continues until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision to terminate.

Also known as: Cohort 20 (vebecotutamab ±lenvatinib)

⑳ Cohort 20 (vebecotutamab ±lenvatinib):

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histopathologic diagnosis of salivary gland carcinoma
• The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
• ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
• Age 18 or older - no upper limit;
• Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and agree to receive the necessary contraceptive measures;
• ⑧The patient must have adequate liver, kidney, bone marrow, heart and lung and other organ functions:
• ⑨Understanding and voluntarily signing informed consent prior to performing any research-related evaluation/operation;
• ⑩Ability to comply with research visit schedules and other programmatic requirements.

You may not qualify if:

• Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
• Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
• Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
• To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
• Major cardiovascular diseases;
• Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
• Is suffering from an active infection that requires systemic treatment;
• History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or compliance of the drug therapy in this study ⑫Female/male who is pregnant or breastfeeding or who intends to give birth;

Sponsors & Collaborators

• Peking Union Medical College: lead
• Peking University Hospital of Stomatology: collaborator

Study Sites (2)

Fei Ma

Beijing, Beijing Municipality, 100021, China

RECRUITING

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Leuprolide; bicalutamide; abiraterone; Platinum; Albumin-Bound Paclitaxel; Carboplatin; apatinib; camrelizumab; Trastuzumab; pyrotinib; pertuzumab; Androgen Receptor Antagonists; Goserelin; Fulvestrant; Poly(ADP-ribose) Polymerase Inhibitors; enfortumab vedotin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Androgen Antagonists; Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Jie Zhang

  Department of Oral and Maxillofacial Surgery, Peking University School and Hospital of Stomatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

fei Ma

CONTACT

13910217780; drmafei@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician and deputy chief of internal medicine

Model Details: The study employs a master-protocol platform design with the primary objective of identifying promising subgroups; new drug regimens may be added during the trial, while ineffective arms are closed based on interim monitoring. The trial consists of two stages. In Stage 1, each experimental arm uses a Bayesian Optimal Phase II (BOP2) design to assess whether the regimen shows sufficient efficacy to warrant further investigation. Arms demonstrating promising activity proceed to Stage 2（Simon two-stage design）.

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: November 24, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): July 10, 2028
• Study Completion (Estimated): July 10, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)