Evaluating QL1706 for Treating Resectable Colon Cancer
Official title: 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
Run by Qilu Pharmaceutical Co., Ltd. · NCT06686576 · Data updated 2026-11-12
This study is testing a new treatment called QL1706 for people with certain types of colon cancer to see if it can help them during their surgery and recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 363 (estimated) |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou) |
| Status | Recruiting |
| Started | December 12, 2024 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | December 18, 2025 |
| Trial ID | NCT06686576 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with untreated, resectable stage IIB-III colon adenocarcinoma exhibiting MSI-H/dMMR characteristics.
✕Probably not a fit
Patients with distant metastatic disease or those who have previously received any form of antitumor therapy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the effectiveness of QL1706 in patients with untreated, resectable colon cancer characterized by microsatellite instability high (MSI-H) or defective mismatch repair (dMMR). Participants will receive QL1706 in conjunction with CAPEOX during the perioperative period. The study focuses on individuals with specific staging of colon cancer to determine the treatment's efficacy and safety. The trial is designed to provide insights into how this intervention can improve outcomes for patients with this type of cancer.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for patients with MSI-H/dMMR colon cancer.
How similar studies have gone: While this approach is focused on a specific treatment for a defined patient population, similar studies targeting MSI-H/dMMR cancers have shown promising results in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou, China Recruiting
Study contacts
- Study coordinator: Ruihua Xu, PhD
- Email: xurh@sysucc.org.cn
- Phone: +086-020-87343468
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.