NCT06973343

Sintilimab Plus Bevacizumab and Chemotherapy in MSS/pMMR Colorectal With no Liver Metastasis

Sintilimab Plus Bevacizumab and Chemotherapy on Treatment in Patients With Advanced no Liver Metastatic MSS/pMMR Colorectal Cancer: Phase II Cohort Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-randomized, open-label, single-center clinical trial to evaluate efficacy and safety of sintilimab plus bevacizumab and chemotherapy on treatment in patients with advanced no liver metastatic MSS/pMMR colorectal cancer

Detailed description

The regimen involves 3-week cycles with bevacizumab (7.5 mg/m2 on days 1) and fixed doses of sintilimab (200 mg on day 1) and chemotherapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints are Objective response rate(ORR), Disease control rate(DCR), Overall survival(OS) and quality of life. Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Group A	Sintilimab 200mg Bevacizumab 7.5mg/kg Oxaliplatin 130mg/m2 Capecitabine 1250mg/m2
DRUG	Group B	Sintilimab 200mg Bevacizumab 7.5mg/kg Irinotecan 150mg/m2 Capecitabine 1250mg/m2

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-02-01
• Completion: 2027-12-01
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: China