Apatinib Combined With Camrelizumab in Treating Participants With Advanced Chordoma

NCT06140732 | Unknown Phase 2

• 1 other identifier: XW-NS-ACCFC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well Camrelizumab combined with Apatinib work in treating participants with chordoma that has spread to other places in the body, which may interfere with the ability of tumor cells to grow and spread.

Conditions

Chordoma; Chemotherapy Effect

Outcome Measures

Primary Outcomes (2)

• Effectiveness: Progression-free survival (PFS)

  To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by adverse event and Progression-free survival.

  6 months

• Incidence and severity of AE

  To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by adverse event and Progression-free survival.

  From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).

Secondary Outcomes (3)

• Overall survival (OS), , disease

  From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).

• Objective response rate (OPR)

  From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).

• Control rate (DCR)

  From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).

Study Arms (1)

camrelizumab combined with apatinib

EXPERIMENTAL

camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd

Drug: camrelizumab and apatinib

Interventions

camrelizumab and apatinib DRUG

camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd

Also known as: Targeted therapy

camrelizumab combined with apatinib

Eligibility Criteria

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

You may not qualify if:

• The standard of blood routine examination should be met (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct) :
• Hemoglobin (Hb) ≥ 80 g/L;
• Neutrophil count (ANC) ≥ 1.5×109/L;
• Platelet count (PLT) ≥ 80×109/L;
• Biochemical examination shall meet the following standards:
• Total bilirubin (TBIL) \< 1.5 ULN;
• ALT and AST \< 2.5ULN, and \< 5ULN in patients with liver metastasis; Alkaline phosphatase \< 5ULN;
• Serum Cr ≤ ULN or endogenous creatinine clearance \> 45 ml/min. 8. Women of childbearing age must have used reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrol, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 60 days after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and for 120 days after the last dose of the trial drug; 9. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.
• Except for those subjects whose toxicity had not recovered from previous antitumor therapy (concurrent chemoradiotherapy, surgical treatment) (alopecia, alkaline phosphatase, glutamine detranspeptase (GGT)) or who could be enrolled after discussion with the investigator and sponsor
• Use of immunosuppressive drugs within 14 days prior to first use of carrilizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones at physiological doses (i.e., no more than 10 mg/ day of prednisolone or other corticosteroids at pharmacologically equivalent doses);
• Previous treatment with anti-PD-1, anti-PD-L1, anti-VEGFR antibodies or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
• Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg, despite systematic medication);
• Severe cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for men and ≥470 ms for women); Grade Ⅲ to Ⅳ cardiac insufficiency (according to the New York Heart Society NYHA classification, see Annex 3), or left ventricular ejection fraction (LVEF) \< 50% indicated by cardiac color ultrasound;
• Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) are not included;
• The subjects were treated with bronchodilators and other systemic treatments, but their asthma control was unsatisfactory and they could not be included (those whose asthma had been completely relieved in childhood could be included without any intervention after adulthood).

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

BEIJING

Beijing, Beijing Municipality, China

RECRUITING

Related Publications (6)

• Somaiah N, Conley AP, Parra ER, Lin H, Amini B, Solis Soto L, Salazar R, Barreto C, Chen H, Gite S, Haymaker C, Nassif EF, Bernatchez C, Mitra A, Livingston JA, Ravi V, Araujo DM, Benjamin R, Patel S, Zarzour MA, Sabir S, Lazar AJ, Wang WL, Daw NC, Zhou X, Roland CL, Cooper ZA, Rodriguez-Canales J, Futreal A, Soria JC, Wistuba II, Hwu P. Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial. Lancet Oncol. 2022 Sep;23(9):1156-1166. doi: 10.1016/S1470-2045(22)00392-8. Epub 2022 Aug 4.

  PMID: 35934010 BACKGROUND

• Liu C, Jia Q, Wei H, Yang X, Liu T, Zhao J, Ling Y, Wang C, Yu H, Li Z, Jiao J, Wu Z, Yang C, Xiao J. Apatinib in patients with advanced chordoma: a single-arm, single-centre, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1244-1252. doi: 10.1016/S1470-2045(20)30466-6.

  PMID: 32888455 BACKGROUND

• Chen Y, Jia Y, Liu Q, Shen Y, Zhu H, Dong X, Huang J, Lu J, Yin Q. Myocarditis related to immune checkpoint inhibitors treatment: two case reports and literature review. Ann Palliat Med. 2021 Jul;10(7):8512-8517. doi: 10.21037/apm-20-2620. Epub 2021 Jul 1.

  PMID: 34263614 BACKGROUND

• Ulici V, Hart J. Chordoma. Arch Pathol Lab Med. 2022 Mar 1;146(3):386-395. doi: 10.5858/arpa.2020-0258-RA.

  PMID: 34319396 BACKGROUND

• DeMaria PJ, Lee-Wisdom K, Donahue RN, Madan RA, Karzai F, Schwab A, Palena C, Jochems C, Floudas C, Strauss J, Marte JL, Redman JM, Dombi E, Widemann B, Korchin B, Adams T, Pico-Navarro C, Heery C, Schlom J, Gulley JL, Bilusic M. Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer. J Immunother Cancer. 2021 Sep;9(9):e003238. doi: 10.1136/jitc-2021-003238.

  PMID: 34479925 BACKGROUND

• Blay JY, Chevret S, Le Cesne A, Brahmi M, Penel N, Cousin S, Bertucci F, Bompas E, Ryckewaert T, Soibinet P, Boudou-Rouquette P, Saada Bouzid E, Soulie P, Valentin T, Lotz JP, Tosi D, Neviere Z, Cancel M, Ray-Coquard I, Gambotti L, Legrand F, Lamrani-Ghaouti A, Simon C, Even C, Massard C. Pembrolizumab in patients with rare and ultra-rare sarcomas (AcSe Pembrolizumab): analysis of a subgroup from a non-randomised, open-label, phase 2, basket trial. Lancet Oncol. 2023 Aug;24(8):892-902. doi: 10.1016/S1470-2045(23)00282-6. Epub 2023 Jul 7.

  PMID: 37429302 RESULT

MeSH Terms

Conditions

Chordoma

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Zan Chen

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zan Chen, Dr.

CONTACT

18131166269; qimaoyang777@163.com

Zan Chen

CONTACT

+861391171212; chenzan66@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 20, 2023
• Study Start: October 30, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 31, 2026
• Last Updated: November 20, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)