Status:
NOT_YET_RECRUITING
QL1706 Plus XELOX as Neoadjuvant Therapy for MSS/pMMR Clinical Stage III Colon Cancer
Lead Sponsor:
Qilu Hospital of Shandong University
Conditions:
Colon Cancer
MSS/pMMR
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a single-arm, exploratory study enrolling participants with resectable stage III pMMR/MSS colon cancer. Eligible participants who provide written informed consent will receive four cycles of n...
Eligibility Criteria
Inclusion
- Age between 18 and 75 years.
- Histologically or clinically confirmed initially resectable Stage III colon cancer according to the AJCC 8th edition.
- ECOG performance status of 0 or 1.
- pMMR/MSS status confirmed by a local testing center.
- No planned neoadjuvant radiotherapy.
- Participants must voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.
- Adequate organ function.
Exclusion
- Stage IV colon cancer.
- Prior treatment with immune checkpoint inhibitors targeting CTLA-4, PD-1, or PD-L1.
- Current participation in another clinical trial and receiving investigational drugs.
- History of or contraindication to severe allergic reactions to immunotherapy.
- Pregnancy or lactation.
- Active infection requiring treatment.
- Use of immunosuppressive medications.
- Active cardiovascular disease, including stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure, or severe uncontrolled arrhythmia requiring medication that may preclude surgery.
- Patients with acute conditions such as obstruction, hemorrhage, or perforation that require immediate surgery.
- Any other condition deemed by the investigator to render the participant unsuitable for the clinical study.
Key Trial Info
Start Date :
September 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT07156682
Start Date
September 25 2025
End Date
June 30 2028
Last Update
September 5 2025
Active Locations (1)
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1
Qilu hospital of Shandong University
Jinan, Shandong, China, 250012