OncoMatch/Clinical Trials/NCT07079462
Comparing 68Ga-FAPI PET-Guided Abdominal Radiotherapy Combined With Second-Line Standard Therapy and Cadonilimab Versus Second-Line Standard Therapy in Colorectal Cancer With Peritoneal Metastasis
Is NCT07079462 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Radiotherapy followed by immunotherapy and chemotherapy for colorectal cancer.
Treatment: Radiotherapy followed by immunotherapy and chemotherapy — Main objective: 1\. To compare the objective response rate (ORR) of 68Ga-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 68Ga-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 68Ga-FAPI PET-guided abdominal region radiotherapy combined with second-line standard treatment versus cabozantinib.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard first-line treatment
Progression after receiving standard first-line treatment before enrollment; but excluding any type of immunotherapy
Cannot have received: immunotherapy
excluding any type of immunotherapy
Cannot have received: anti-PD-1 therapy
Any patient who has received any anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody (or any other antibody acting on the T cell co-stimulation or checkpoint pathways) before enrollment
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L; platelets ≥ 100 × 10^9/L (≥ 80 × 10^9/L with liver metastasis); hemoglobin ≥ 9 g/dL; no blood transfusion within 2 weeks prior to enrollment
Kidney function
Serum creatinine ≤ 1.5x ULN, or creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula)
Liver function
Serum total bilirubin ≤ 1.5x ULN (≤ 2.5x ULN with liver metastasis); AST/ALT ≤ 2.5x ULN (≤ 5x ULN with liver metastasis)
Cardiac function
LVEF ≥ 50%; no NYHA class 2 or above heart dysfunction; no congestive heart failure, acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months
Laboratory tests for bone marrow, liver and kidney organ functions and coagulation function within 7 days before the first administration were in compliance with the study requirements... See exclusion criteria for specific thresholds
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07079462 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy, anti-PD-1 therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages