drugset / Trial / NCT07079462

Comparing 18F-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis

NCT07079462 ↗

Phase 2 Recruiting 40 enrolled Fudan University
RandomizedParallel-groupOpen-labelTreatment

Summary

Main objective: 1\. To compare the objective response rate (ORR) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. Secondary objectives: 1. To compare the disease control rate (DCR), duration of continuous remission (DoR), progression-free survival (PFS) and overall survival (OS) of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib and second-line standard treatment in the treatment of peritoneal metastasis of colorectal cancer. 2. To evaluate the safety and tolerability of 18F-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.

Timeline

Start
2024-08-07
Primary completion
2026-01-31
Completion
2028-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cadonilimab Monoclonal antibody 6 mg/kg —
Comparator Bevacizumab Monoclonal antibody — —
Comparator Cetuximab Monoclonal antibody — —