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

December 11, 2025 updated by: Qilu Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

363

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • Recruiting
        • Affiliated Cancer Hospital of Sun Yat-sen University
        • Contact:
          • Rui hua Xu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Phase Ib/Ⅲ Participants will receive QL1706 pre surgery
Drug: QL1706
Phase Ib/Ⅲ： QL1706 will be administered
Active Comparator: Phase III Control group
Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.
Drug: CAPEOX/Capecitabine
Phase Ⅲ：CAPEOX/Capecitabine will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 month after surgery
Event Free Survival, EFS(EFS), defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery.
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as time from randomization to death from any cause
Up to approximately 5 years
Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment
Time Frame: Up to approximately 5 years
Up to approximately 5 years
R0 tumor resection rate
Time Frame: 2 week after surgery
R0 tumor resection rate is defined as the proportion of subjects with R0 excision
2 week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2024

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 11, 2024

First Posted (Actual)

November 13, 2024

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QL1706-307

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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