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

NCT05236972 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2022-12-30

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Carcinoma

Interventions

DRUG

Sintilimab

Sintilimab 200mg iv drip Q3W

DRUG

Oxaliplatin

130 mg/m² iv drip over 2 hours on day 1, repeated every 21 days.

DRUG

capecitabine

1000 mg/m² po twice daily on days 1- 14 repeated every 21 days

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2026-06-01
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236972 on ClinicalTrials.gov