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

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: Colon Cancer
• Intervention / Treatment: Drug: QL1706; Drug: CAPEOX/Capecitabine

• Study Type: Interventional
• Enrollment (Estimated): 363
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Ruihua Xu, PhD; Phone Number: +086-020-87343468; Email: xurh@sysucc.org.cn

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	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.	Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	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		Up to approximately 5 years
R0 tumor resection rate	R0 tumor resection rate is defined as the proportion of subjects with R0 excision	2 week after surgery

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

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: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Colonic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine
• 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