RecruitingPhase 3NCT06686576

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

363 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Colon Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

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 Criteria5

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