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Clinical Trials in China / NCT06686576
Recruiting Phase 3

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

NCT06686576 · tracked via the Priya Life Science China tracker
Sponsor
Qilu Pharmaceutical Co., Ltd
Phase
Phase 3
Started
2024-12-12
Last updated
2025-12-18

Condition(s) studied

Colon Cancer

Investigational drug(s) / intervention(s)

QL1706 →CAPEOX/Capecitabine

QL1706: Phase Ib/Ⅲ： QL1706 will be administered

CAPEOX/Capecitabine: Phase Ⅲ：CAPEOX/Capecitabine will be administered

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Affiliated Cancer Hospital of Sun Yat-sen University Guangzhou China Recruiting

More Qilu Pharmaceutical Co., Ltd. trials in China

Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction Recruiting
Study on the Efficacy and Safety of QLM1016 in Schizophrenia Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP Recruiting
Efficacy and Safety Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis Recruiting
Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors Recruiting

Other trials for the same condition

Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer Recruiting
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer Starting soon
The Role of Total Abdominal Autonomic Nerve Preservation During the Resection of Right/Left Colon Cancer: Prospective Clinical Trial Active, not recruiting
Clinical Study of CEA Targeting Chimeric Antigen Receptor T Lymphocytes（CAR-T） for CEA Positive Advanced Malignant Solid Tumors Recruiting
QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06686576 on ClinicalTrials.gov ↗ ← All trials in China