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

Phase 3

Recruiting

• Conditions: Colon Cancer
• Interventions: Biological: QL1706; Drug: CAPEOX

• Registration Number: NCT06686576
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-13
• Study Start: 2024-12-12
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 288

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	QL1706	Phase Ib/Ⅲ Participants will receive QL1706 pre and post surgery
Phase III Control group	CAPEOX	Participants will receive SOC (CAPEOX) or undergo expectant observation post surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
R0 tumor resection rate	2 week after surgery	R0 tumor resection rate is defined as the proportion of subjects with R0 excision
Overall Survival (OS)	Up to approximately 5 years	OS is defined as time from randomization to death from any cause
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

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, China