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NCT Number: NCT06686576

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

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

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Affiliated Cancer Hospital of Sun Yat-sen University

Guangzhou, China

Location status: Recruiting

Location contact

Rui hua Xu, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QL1706

Drug

Phase Ib/Ⅲ： QL1706 will be administered

CAPEOX/Capecitabine

Drug

Phase Ⅲ：CAPEOX/Capecitabine will be administered

Primary outcomes

  1. 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.

    Time frame: 1 month after surgery

  2. 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.

    Time frame: Up to approximately 5 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 5 years

    OS is defined as time from randomization to death from any cause

  2. R0 tumor resection rate

    Time frame: 2 week after surgery

    R0 tumor resection rate is defined as the proportion of subjects with R0 excision

  3. 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

    Time frame: Up to approximately 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ruihua Xu, PhD

CONTACT

[email protected]

+086-020-87343468

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Nov 13, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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