Tislelizumab Combined With Chemotherapy in the Treatment of Bone Metastases of Unknown Primary

NCT05241132 | Unknown Phase 2 DMC

• 1 other identifier: 2021SL047
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Through scientific and rigorous design, implementation, follow-up and statistics, the sponsor aims to explore the clinical efficacy and safety of Tislelizumab combined with chemotherapy (platinum + paclitaxel) in the treatment of patients with bone metastases cancer with unknown primary, and provide a better treatment plan for these patients.

1. 1.Primary outcome: Objective response rate (ORR)
2. 2.Secondary outcomes: disease control rate (DCR), duration of remission (DOR), progression-free disease (PFS), overall survival (OS), median PFS, median OS, stratification based on clinical features and PD-L1 expression, adverse reactions (AEs), and quality of life.

Conditions

Cancer of Unknown Primary; Bone Cancer Metastatic; Tislelizumab; Gene Mutation-Related Cancer; Immune Evasion, Tumor; Chemotherapy Effect

Keywords

Bone metastases from cancer of unknown primary; Cancer of unknown primary; Tislelizumab; Chemotherapy Effect; Immunotherapy; Gene expression spectrum

Outcome Measures

Primary Outcomes (1)

• Complete Response(CR) and Partial Response(PR) in all participants according to RECIST,v1.1

  Proportion of patients whose tumor volume shrinks to a predetermined value and maintains the minimum time limit

  3 years

Secondary Outcomes (9)

• Disease control rate（DCR）according to RECIST,v1.1

  3 years

• Duration of remission (DOR) by Kaplan-Meier

  3 years

• Progression Free Survival (PFS) by Kaplan-Meier

  3 years

• Overall survival (OS) by Kaplan-Meier

  3 years

• The median of Progression Free Survival (PFS) by Kaplan-Meier

  3 years

Study Arms (1)

BMCUP treated with Tislelizumab and chemotherapy

EXPERIMENTAL

Patients with bone metastases from cancer of unknown primary (BMCUP) diagnosed according to the criteria defined in the 2015 European Society of Medical Oncology (ESMO) clinical Practice Guidelines and with bone metastases confirmed by imaging and histology that cannot be completely resected 1. Cisplatin: 100mg/m2, injected intravenously every 3 weeks, 8 cycles (period 21 days) 2. Paclitaxel (albumin-bound) : paclitaxel, 175mg/m2, given intravenously every 3 weeks for 8 cycles (period 21 days). 3. Tislelizumab: 200mg, given intravenously every 3 weeks until disease progression or unacceptable toxicity or death or subject withdrawal of informed consent.

Drug: Tislelizumab plus chemotherapy

Interventions

Tislelizumab plus chemotherapy DRUG

1. Cisplatin: 100mg/m2, injected intravenously every 3 weeks, 8 cycles (period 21 days) 2. Paclitaxel (albumin-bound) : paclitaxel, 175mg/m2, given intravenously every 3 weeks for 8 cycles (period 21 days). 3. Tislelizumab: 200mg, given intravenously every 3 weeks until disease progression or unacceptable toxicity or death or subject withdrawal of informed consent.

Also known as: Cisplatin, Paclitaxel

BMCUP treated with Tislelizumab and chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide written informed consent/consent for the trial.
• Be at least 18 years old on the day of signing the informed consent.
• Patients with bone metastases from cancer of unknown primary (BMCUP) diagnosed according to the criteria defined in the clinical practice guidelines of the European Society of Medical Oncology (ESMO) in 2015 and confirmed by imaging and histology to have bone metastases that cannot be completely resected.
• Did not receive systemic treatment.
• Have at least one measurable lesion according to RECIST1.1, willing to agree to archived tumor (in formalin fixed paraffin-embedded (FFPE) block) or fresh tumor material (cryogenic refrigerator or liquid nitrogen storage).
• ECOG performance level 0 or 1 point.
• The expected survival time is ≥3 months.
• Adequate organ and bone marrow functions (all screening tests should be performed within 10 days of the start of treatment) :A) Absolute neutrophil count ≥1.5x109 /L.B) Platelet ≥100x109 /L.C) Hemoglobin ≥9g/dL(≥90g/L).D) No blood transfusion or erythropoietin dependence (within 7 days of evaluation).E) Serum creatinine ≤1.5x upper normal limit (ULN) or creatinine level \> 1.5xULn, creatinine clearance ≥60 ml/min (creatinine clearance should be calculated according to institutional criteria).F) Patients with serum total bilirubin ≤1.5xULN or total bilirubin level \> 1.5ULN, direct bilirubin ≤ULN.G) Aspartate aminotransferase ≤2.5xULN(if liver metastasis is present).H) Alanine aminotransferase ≤2.5xULN(if liver metastasis is present).I) Albumin ≥2.5g/dL.J) International standardized ratio (INR) or prothrombin time ≤1.5xULN(if subject is being treated with anticoagulant, prothrombin time or partial prothrombin time should be within the range expected for treatment with anticoagulant).K) Activated partial thrombin time ≤1.5xULN(prothrombin time or partial prothrombin time should be within the expected therapeutic range of anticoagulant use).L) Women with reproductive potential should undergo a mandatory serum-negative pregnancy within 72 hours prior to receiving the first dose of the study drug.M) Fertile female subjects must be willing to use appropriate contraceptive methods during the study up to 120 days after the last use of the study drug.Note: Abstinence is acceptable if this is the subject's usual lifestyle and preferred method of contraception.N) Male subjects with reproductive potential must consent to use appropriate contraceptive methods from the first study treatment until 120 days after the last study treatment.

You may not qualify if:

• Unknown primary lesion of squamous cells.
• in suspected lymphoma (e.g., leukocyte common antigen staining), malignant melanoma (for example, according to dye and beta hCG), gonads germ cell tumor (such as AFP and human chorionic gonadotropin), sarcoma (such as cell keratin and vimentin staining), neuroendocrine tumor (such as chromaffin granulocyte and synaptic staining).And male prostate cancer (e.g., prostate specific antigen staining).
• apply to specific treatment, the patients of group (for example, only axillary lymph node metastasis of adenocarcinoma patients, peritoneal papillary serous carcinoma patients, only involving the neck, or groin lymph nodes of patients with squamous cell carcinoma, prompt germ cell tumors and beta hCG and/or AFP levels of patients with poorly differentiated carcinoma, and involves a single potentially resectable cancer patients).
• Currently participating in and receiving study therapy, or participating in a study formulation and receiving study therapy or using study drug within 4 weeks of the first dose.
• Confirmed immunodeficiency or receiving documented systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to receiving the first dose of tirelizumab.
• Have active tuberculosis.
• Have an allergic reaction to the study drug.
• One has received radiotherapy within 14 days before the first treatment. If the subjects received radiotherapy, they must fully recover from the toxicity and / or complications caused by the intervention, according to the judgment of a qualified investigator, before starting the treatment.
• Have received chemotherapy treatment.
• Subjects must fully recover from surgery and related complications in the judgment of a qualified investigator prior to the initiation of treatment.
• There is another known malignancy developing or requiring aggressive treatment.Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin, squamous cell carcinoma of the skin that has received potential treatment, or cervical carcinoma in situ.
• Active central nervous system (CNS) metastases and/or cancerous meningitis are known.Brain metastasis treated subjects as long as they received in a stable condition (in the treatment of at least four weeks before the first trials there was no evidence of progress examined by CT or MRI brain, any neurological symptoms has returned to baseline), there was no evidence of brain metastases from new or expanded, and at least 7 days prior to treatment did not use steroids, can attend the test.This exception does not include cancerous meningitis, which is excluded regardless of clinical stability.
• Active autoimmune disease requiring systematic treatment (i.e. disease improvers, corticosteroids, or immunosuppressants) within the past two years.
• Having (noninfectious) pneumonia or a history of current pneumonia.
• There is an active infection that requires systematic treatment.

Sponsors & Collaborators

• Wei Xu: lead

Study Sites (1)

ChangZheng Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

tislelizumab; Drug Therapy; Cisplatin; Paclitaxel

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jianru Xiao, Profession

  Chang Zheng Hospital

  STUDY CHAIR

• Wei Xu, Profession

  Chang Zheng Hospital

  STUDY DIRECTOR

• Bo Li, Profession

  Chang Zheng Hospital

  PRINCIPAL INVESTIGATOR

• Hao Jiang, Doctor

  Chang Zheng Hospital

  PRINCIPAL INVESTIGATOR

• Pengru Wang, Doctor

  Chang Zheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Xu, Doctor

CONTACT

13761278657; xuweichangzheng@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Prior to enrollment in the study, doctors asked and recorded the patient's medical history, and if eligible participants volunteered to participate in the study, they would sign informed consent.If they are not willing to participate in the study, we will do the usual treatment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Orthopaedic department of Changzheng Hospital

Model Details: This is a prospective, single-arm, open phase II clinical study

Study Record Dates

• First Submitted: January 23, 2022
• First Posted: February 15, 2022
• Study Start: November 12, 2021
• Primary Completion: June 30, 2023
• Study Completion: October 31, 2024
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After completion
• Access Criteria: 1111

Locations

CN (1)