A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy

Approximately 20-50% of patients with colorectal cancer (CRC) develop distant metastasis after curative surgery, and those with early relapse within one year of completing adjuvant chemotherapy (XELOX or FOLFOX) have a particularly poor prognosis and limited treatment options. Standard second-line therapy with FOLFIRI plus targeted therapy (bevacizumab or cetuximab) often yields suboptimal outcomes in this population. Moreover, over 95% of these patients have pMMR/MSS tumors, which are inherently resistant to immune checkpoint inhibitor monotherapy. This phase II, prospective, randomized tria

Trial Details

NCT ID
NCT07604909
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Serplulimab
  • Second-Line Chemo/Targeted Therapy
Locations (sample)
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • Age ≥18 years, male or female. Histologically confirmed early relapse (within 1 year after surgery, UICC stage IV) of colorectal cancer after adjuv…
  • Have received standard postoperative adjuvant chemotherapy (XELOX or FOLFOX). Before enrollment, tumor tissue tested by immunohistochemistry as pMM…
  • At least one measurable tumor lesion according to RECIST 1.1 criteria. ECOG performance status 0-1. Life expectancy ≥3 months.
  • Adequate organ function:

For full eligibility, visit ClinicalTrials.gov.

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