A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study

The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.

Trial Details

NCT ID
NCT05954429
Phase
PHASE2
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • serplulimab
  • Fruquintinib
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Age ≥18 years old, both sexes;
  • Patients with histologically or cytologically confirmed unresectable and metastatic CRC
  • non-liver-limited metastasis: including no liver metastasis or liver metastasis accompanied by other metastatic lesions, such as lung metastasis, p…
  • Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;

For full eligibility, visit ClinicalTrials.gov.

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