Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC

This is an exploratory, non-controlled, multi-cohort, phase II small-sample clinical study designed to evaluate the clinical benefit of second-line treatment with anlotinib plus irinotecan or further in combination with a PD-1 monoclonal antibody (penpulimab) in patients with advanced colorectal cancer after first-line treatment failure. To explore the rationality of the combination of chemotherapy and targeted therapy and immunotherapy strategy and obtain relevant survival and safety data. The study will fully evaluate the efficacy, PFS, OS, safety and related biomarkers of the regimen.

Trial Details

NCT ID
NCT05229003
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Anlotinib
  • Penpulimab
  • Irinotecan
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Recurrent/metastatic colorectal adenocarcinoma confirmed by histopathological pathology report;
  • The patient received oxaliplatin in combination with fluorouracil as the first-line systemic therapy (with or without anti-EGFR mab or VEGF mab) an…
  • With one or more measurable lesions, the longest diameter measured by spiral CT scan should be at least 10 mm, and the longest diameter measured by…
  • the type of KRAS, NRAS, BRAF, and MSI were known, requiring wild type of BRAF. Cohort A required patients with MSS/pMMR status.

For full eligibility, visit ClinicalTrials.gov.

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