Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT06140732
Status:
RECRUITING
Last Update Posted:
2023-11-20
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Apatinib Combined With Camrelizumab in Treating Participants With Advanced Chordoma
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
A Single-arm Phase 2 Study of Apatinib (Anti-PD-1) Combined With Camrelizumab (Anti-VEGFR ) in Patients With Advanced Chordoma
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: