Clinical Trial

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

Active, Not Recruiting Phase 2
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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 cadonilimab 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 cadonilimab 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 cadonilimab.
Protocol Amendment History 2 changes
critical Enrollment closed, study ongoing 2026-08-13
minor Completion moved earlier: 2028-05-01 -> 2028-01-31 2026-07-03
Trial Details
NCT Number NCT07079462
Lead Sponsor Fudan University
Conditions Colorectal Cancer, Peritoneal (Metastatic) Cancer, FAPI PET
Enrollment 40 participants
Start Date 2024-08-07
Primary Completion 2026-01-31 (estimated)
Study Completion 2028-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-12