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NCT06686576RecruitingPhase 3

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

Source: ClinicalTrials.gov · Last updated 18 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
363 (estimated)
First submitted
11 Nov 2024
Start date
12 Dec 2024
Primary completion date
Dec 2030
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
NCT number
NCT06686576

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 363
  • From 12 Dec 2024 to the primary completion date, Dec 2030
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previously received any antitumor therapy for the disease under study, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Affiliated Cancer Hospital of Sun Yat-sen University
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.