NCT06140732

Apatinib Combined With Camrelizumab in Treating Participants With Advanced Chordoma

A Single-arm Phase 2 Study of Apatinib (Anti-PD-1) Combined With Camrelizumab (Anti-VEGFR ) in Patients With Advanced Chordoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by adverse events (AEs) and progression free survival (PFS). SECONDARY OBJECTIVES: I. Ascertain the safety of nivolumab in combination with relatlimab in subjects with metastatic or locally advanced/unresectable chordoma by the Overall survival (OS), objective response rate (MPR) and disease control rate (DCR) EXPLORATORY OBJECTIVES: I. Compare response rate (RR) and clinical benefit rate (CBR) in patients whose tumors are PD-L1+ and PD-L1- at baseline. II. Compare RR and CBR in patients whose tumors are VEGFR+ and VEGFR- at baseline. III. In the patients who are PD-L1 positive, compare RR and CBR in patients with 1% and 5% tumor membrane staining. III. Determine the response to treatment based on the baseline mutation load. IV. Determine the ORR and CBR via Choi criteria. OUTLINE: To evaluate the safety and tolerability of carrilizol combined with apatinib in patients with recurrent, unresectable, chemotherapy-failed chordoma After completion of study treatment, participants are followed up within 3 months.

Conditions

• Chordoma
• Chemotherapy Effect

Interventions

Type	Name	Description
DRUG	camrelizumab and apatinib	camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-01-01
• Completion: 2026-01-31
• First posted: 2023-11-20
• Last updated: 2023-11-20

Locations

1 site across 1 country: China