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AK104 in Locally Advanced MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 29 to 47v2 Show 5 more changesShow less
    • Primary completion date: Oct 2022 to Dec 2026
    • Start date changed from estimate of Oct 2020 to Feb 28, 2024
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Study completion date: Oct 2023 to Dec 2028
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Peking University
118 trials monitored
See 4 trials at risk
Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Gastric Cancer
1,278 trials monitored
See 63 trials at risk
This is a single-arm, multicenter phase II clinical study. The aim is to evaluate the safety, tolerability, and anti-tumor activities of AK104(a PD-1/CTLA-4 bispecific antibody) in MSI-H/dMMR locally advanced gastric adenocarcinoma and colorectal cancer during the perioperative period.Eligible patients will receive AK104 for three cycles before surgery and at most 6 months after surgery. The primary endpoint is the pathological complete response rate.
Trial Details
NCT Number NCT04556253
Lead Sponsor Peking University
Conditions
(from sponsor)		 MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
Related terms Colorectal Neoplasms
Enrollment 47 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov