Phase Ⅱ Clinical Trial of Cadonilimab Combined With Anti-angiogenic Agents in Metastatic dMMR/MSI-H CRC

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 cadoni

Trial Details

NCT ID
NCT07003022
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • cadonilimab combined with an anti-angiogenic agent, which is selected by the investigator from bevacizumab, regorafenib, or fruquintinib.
Locations (sample)
  • Shanghai, China, China|31.22222,121.45806

Key Eligibility Criteria

  • \- Signed written informed consent prior to enrollment. Age 18-80 years. dMMR or MSI-H Diagnosis confirmed by histological examination and/or cytol…
  • ECOG score: 0 to 2. At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan…
  • Adequate organ function with. Routine blood: Absolute Neutrophil Count (ANC) 1.5 × 109/L, Platelets (Platelet, PLT) ≥ 100 × 109/L, Hemoglobin (HGB)…
  • Liver function: Total Bilirubin (TBIL) ≤ 1.5 × Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3…

For full eligibility, visit ClinicalTrials.gov.

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