Actively Recruiting
A Phase Ib/III, Open-Label, Randomized Study of Neoadjuvant QL1706 Versus Standard of Care in Participants With Untreated Microsatellite Instability-High or Mismatch Repair-Deficient, Resectable Colon Cancer
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-12-18
363
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of neoadjuvant QL1706 in people with untreated T4N0 or Stage III (resectable), microsatellite instability high/defective mismatch repair (MSI-H/dMMR) colon cancer. This study focuses on participants with colon adenocarcinoma that can be surgically removed and aims to compare QL1706 with the current standard care treatments. The trial is an open-label, randomized Phase Ib/III study sponsored by Qilu Pharmaceutical Co., Ltd. Participants in the Phase Ib/II part will receive QL1706 before surgery. After surgery, participants are randomly assigned to receive either standard care chemotherapy with CAPEOX/Capecitabine or undergo expectant observation. The study includes treatment and follow-up phases to monitor outcomes and safety over time. During the study, participants will undergo assessments including surgery and pathological examination to measure the complete response rate one month after surgery. Researchers will track event-free survival, overall survival, tumor removal success, and treatment side effects for up to approximately 5 years. Participants will be closely monitored for adverse events, immune-related reactions, and treatment tolerability throughout the study period.
CONDITIONS
Brief Title
A Study of Neoadjuvant QL1706 in Participants With Untreated dMMR/MSI-H Resectable Colon Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Untreated pathologically confirmed colon adenocarcinoma
- Radiographic assessment showing resectable stage IIB-III based on AJCC Stage VIII (cT4 or cN+ only)
- Tumor demonstrating the presence of MSI-H or dMMR
- Adequate organ function as described in the protocol
You will not qualify if you...
- Previous antitumor therapy for the disease, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Presence of distant metastatic disease
- Active autoimmune disease requiring systemic treatment in the past 2 years
- Known history or evidence of interstitial lung disease
- Active infection requiring systemic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to surgery date
Participants receive neoadjuvant QL1706 treatment before surgery.
1 to 2 visits before surgery
Duration - Up to 2 weeks after surgery
Participants undergo surgery to remove the tumor followed by immediate post-operative care.
1 surgery visit and approximately 1 post-operative visit
Duration - Up to approximately 5 years
Participants receive standard of care treatment including CAPEOX/Capecitabine or undergo expectant observation after surgery.
Regular visits during treatment and observation period
Duration - Up to approximately 5 years
Participants are monitored for up to approximately 5 years for event-free survival, overall survival, and adverse events.
Periodic visits for long-term monitoring
Trial Site Locations
Total: 1 location
1
Affiliated Cancer Hospital of Sun Yat-sen University
Guangzhou, China
Actively Recruiting
Research Team
R
Ruihua Xu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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