Status:
NOT_YET_RECRUITING
QL1706 With Short-Course Radiotherapy and Chemotherapy for MSS Rectal Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Locally Advanced Rectal Cancer (LARC)
Mismatch Repair-Proficient (pMMR) Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a multicenter, prospective, phase II study evaluating total neoadjuvant therapy (TNT) consisting of short-course radiotherapy (SCRT; 5×5 Gy) followed by QL1706 (a bifunctional MabPair antibody...
Eligibility Criteria
Inclusion
- Age 18-75 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Locally advanced disease (cT3-4 and/or N+, M0) based on pelvic MRI and/or CT.
- Tumor located within 12 cm from the anal verge.
- Proven microsatellite stability (MSS) or proficient mismatch repair (pMMR) status.
- ECOG performance status 0-1.
- Adequate organ function:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Platelet count ≥ 100 × 10⁹/L
- Hemoglobin ≥ 90 g/L
- ALT/AST ≤ 2.5 × ULN
- Total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min
- No prior pelvic radiotherapy, chemotherapy, immunotherapy, or targeted therapy for rectal cancer.
- Signed written informed consent
Exclusion
- Evidence of distant metastasis.
- Previous or concurrent malignant tumor (except cured basal cell carcinoma of skin or cervical carcinoma in situ).
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis.
- Known allergy or hypersensitivity to study drugs or excipients.
- Uncontrolled cardiovascular disease (e.g., recent myocardial infarction, unstable angina, congestive heart failure, arrhythmia).
- Pregnant or breastfeeding women.
- Any condition judged by investigators to make the patient unsuitable for the study.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2029
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07175636
Start Date
September 20 2025
End Date
September 20 2029
Last Update
September 16 2025
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