OncoMatch/Clinical Trials/NCT07003022
Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC
Is NCT07003022 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib. for colo-rectal cancer.
Treatment: cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib. — This study is a prospective, open-label, dual-arm exploratory Phase II clinical trial designed to assess the efficacy and safety of cadonilimab combined with anti-angiogenic agents in patients with dMMR/MSI-H recurrent or metastatic colorectal cancer. Eligible patients are enrolled into two cohorts based on their prior exposure to PD-1/PD-L1 antibody therapy: Cohort A (immune-naive group - patients with no prior PD-1/PD-L1 treatment) and Cohort B (immune rechallenge group - patients who previously received and failed PD-1/PD-L1 therapy). All participants receive combination therapy with cadonilimab and an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib. Treatment continues until the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, death, other conditions deemed by the investigator to warrant discontinuation, or study termination-whichever occurs first. Cadonilimab treatment will not exceed two years. Tumor response is evaluated every six weeks using RECIST v1.1 criteria. Safety is assessed using CTCAE v5.0, and adverse events are recorded from the first dose to 30 days after the end of treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Tumor Agnostic
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: pd-1/ctla-4 dual immunotherapy
Lab requirements
Blood counts
ANC 1.5 × 10^9/L, Platelets ≥ 100 × 10^9/L, Hemoglobin ≥ 90 g/L
Kidney function
Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
Liver function
Total Bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤3×ULN; serum albumin ≥30 g/L; after conventional hepatoprotective treatment meeting the above criteria, and can be stable for at least 1 week after evaluation by the investigator can be enrolled.
Adequate organ function with. Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 10^9/L, Platelets (PLT) ≥ 100 × 10^9/L, Hemoglobin (HGB) ≥ 90 g/L. Liver function: TBIL ≤ 1.5 × ULN; ALT and AST ≤3×ULN; serum albumin ≥30 g/L; after conventional hepatoprotective treatment meeting the above criteria, and can be stable for at least 1 week after evaluation by the investigator can be enrolled. Renal function: Creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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