NCT06513221

A Prospective Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab

A Prospective, Multi-arm, Phase II Clinical Study of MSS-type Metastatic Colorectal Cancer Receiving Multiple Lines of Standard Chemotherapy, Bevacizumab Combined With Adebrelimab Under the Guidance of Transcriptome Profiling.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-arm, phase II clinical trial that uses transcriptome profiling to guide the evaluation of the efficacy of multiple lines of standard chemotherapy and bevacizumab combined with adebrelimab in patients with MSS-type metastatic colorectal cancer, aiming to expand the immunotherapy cohort while accurately narrowing the population of MSS-type colorectal cancer that benefits from immunity. This study includes a screening period, a treatment period, and a follow-up period.

Detailed description

This study plans to include a total of 100 first-line, second-line, and third-line MCRIH (MSS Colorectal Cancer Immuno-Hot) participants. First-line and second-line participants who pass the screening period will receive standard chemotherapy (XELOX/mXELIRI: conventional dose) combined with Bevacizumab (7.5mg/kg, q3w) and Adebrelimab (1200mg, q3w); third-line subjects will receive Fruquintinib (4mg po d1\~d14, q3w) combined with Adebrelimab (1200mg, q3w). Participants will receive imaging examinations during the treatment period to evaluate efficacy and progression. In addition, any adverse reactions at any time will be recoded to evaluate safety. The EDC system will be used to collect statistics on participants examination data.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy, Bevacizumab, Adebrelimab	Adebrelimab: 1200mg，q3w Bevacizumab: 7.5mg/kg，q3w Fruquintinib: 4mg po d1\~d14, q3w Chemotherapy: XELOX/mXELIRI: conventional dose

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-04-01
• Completion: 2027-04-12
• First posted: 2024-07-22
• Last updated: 2024-07-22