NCT06231017

Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer

A Single-arm, Open-label, Phase Ⅱ Clinical Trial of Adebrelimab Plus Cetuximab and Chemotherapy for Patients With RAS/BRAF Wild-Type Unresectable Liver Metastases Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.

Detailed description

Colorectal cancer is the third largest malignant tumor in the world and a significant cause of cancer-related deaths. The probability of simultaneous liver metastasis in colorectal cancer is about 25%, and the proportion of liver metastasis occurring in the entire disease process is as high as 40% -50%. It is of great clinical significance to transform the initial unresectable liver metastases of colorectal cancer into resectable ones to improve the overall survival rate and prognosis of colorectal cancer patients. We designed a single-arm, open phase II clinical trial of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer. The purpose of this study is to observe and evaluate the efficacy and safety of adebrelimab plus cetuximab and chemotherapy for patients with RAS/BRAF wild-type unresectable liver metastases colorectal cancer.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Adebrelimab + Cetuximab+ Chemotherapy	Adebrelimab:1200 mg, D1, Q2W+Cetuximab:500 mg, D1, Q2W+FOLFOX6(Q2W) or FOLFIRI(Q2W) until PD or resectability or to max 12 cycles

Timeline

• Start date: 2024-01-19
• Primary completion: 2025-01-19
• Completion: 2026-01-19
• First posted: 2024-01-30
• Last updated: 2024-01-30

Locations

1 site across 1 country: China