A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer

Sponsor
Qilu Pharmaceutical Co., Ltd.
Study ID
NCT06686576
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 — DRUG
    Phase Ib/Ⅲ： QL1706 will be administered
  • CAPEOX/Capecitabine — DRUG
    Phase Ⅲ：CAPEOX/Capecitabine will be administered

Study Details

The goal of this clinical trial is to evaluate the efficacy of neoadjuvant QL1706 in participants with untreated T4N0 or Stage III (resectable), microsatellite instability high/ defective mismatch repair (MSI-H/dMMR) colon cancer

Key Dates

First listed
Nov 13, 2024
Start date
Dec 12, 2024
Status verified
Dec 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
363 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Phase Ib/Ⅲ Participants will receive QL1706 pre surgery
  • Active Comparator: Phase III Control group
    Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.

Primary Outcome Measure

Pathological Complete Response(pCR), defined as the proportion of subjects with no residual tumor in the primary tumor removed and in all lymph nodes removed after neoadjuvant therapy. [ Time Frame: 1 month after surgery ]

Central Contacts

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