Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-24 @ 9:29 PM
NCT ID:
NCT06140732
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.
Study:
NCT06140732
Study Brief:
Protocol Section:
NCT06140732