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A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

NCT06686576•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed written informed consent;
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Untreated pathologically confirmed colon adenocarcinoma
•Radiographic assessment showed a resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only).
•Has a tumor demonstrating the presence of MSI-H/ dMMR
•Adequate organ function as described in the protocol

Exclusion Criteria

•Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc
•Has distant metastatic disease.
•Has an active autoimmune disease that has required systemic treatment in past 2 years
•Has know history of, or any evidence of interstitial lung disease;
•Has an active infection requiring systemic therapy

Locations (1)

Affiliated Cancer Hospital of Sun Yat-sen University

Guangzhou, China

Key Dates

Start Date

December 12, 2024

Primary Completion Date

December 1, 2030

Completion Date

December 1, 2030

Last Updated

December 18, 2025

Enrollment

363

ESTIMATED participants

Conditions

Colon Cancer

Interventions

QL1706

DRUG

CAPEOX/Capecitabine

DRUG

Contacts

Ruihua Xu, PhD

CONTACT

+086-020-87343468 xurh@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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