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

NCT06686576 | Recruiting Phase 3

• 1 other identifier: QL1706-307
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Overall Survival (OS)

  Up to approximately 5 years

• R0 tumor resection rate

  2 week after surgery

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Phase Ib/Ⅲ Participants will receive QL1706 pre surgery

Drug: QL1706

Phase III Control group

ACTIVE COMPARATOR

Participants will receive SOC (CAPEOX/Capecitabine) or undergo expectant observation post surgery.

Drug: CAPEOX/Capecitabine

Interventions

QL1706 DRUG

Phase Ib/Ⅲ： QL1706 will be administered

Experimental group

CAPEOX/Capecitabine DRUG

Phase Ⅲ：CAPEOX/Capecitabine will be administered

Phase III Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Affiliated Cancer Hospital of Sun Yat-sen University

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Ruihua Xu, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 13, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

CN (1)