PACE: PD-1 Antibody For dMMR/MSI-H Stage III Colorectal Cancer

In this open-label phase III study, patients with local advanced colon cancer (TanyN+ ,M0, dMMR/MSI-H, at least 10cm from the anus verge)will be scheduled to Group A: receive anti-PD-1 antibody alone (8 cycles, 200mg iv drip Q3W) and Group B (4 or 8 cycles of XELOX: oxaliplatin 130mg/m2 day 1, capecitabine 2000mg/m2 days 1-14, repeated every 21 days). The primary endpoint was 3 Disease-free survival; analyses were done based on all patients with post-randomization data.

Trial Details

NCT ID
NCT05236972
Phase
PHASE3
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Sintilimab
  • Oxaliplatin
  • capecitabine
Locations (sample)
  • Guangzhou, China|23.11667,113.25

Key Eligibility Criteria

  • Male or female subjects aged ≥18 years
  • ECOG PS 0/1
  • Histologically proven, stage III (i.e., any T, N1 or N2, M0) adenocarcinoma of the colon (as defined by the presence of the inferior pole of the tu…
  • Fully surgically resected tumour with clear resection margins (i.e., \>1 mm)

For full eligibility, visit ClinicalTrials.gov.

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