Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
A Multicenter, Randomized, Parallel, Non-Controlled, Prospective Phase II Study of Neoadjuvant Short-Course Radiotherapy Sequential With AK112 With or Without Chemotherapy for Locally Advanced Rectal Cancer
Sponsor: fan li
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Complete Response Rate
Time frame: From treatment initiation to post-neoadjuvant therapy evaluation (approximately 12 weeks).
Secondary Endpoints
Adverse Events (AEs)
Major Pathological Response (MPR)
Objective Response Rate (ORR)
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent. 2. Age 18-80 years, male or female. 3. Histologically confirmed rectal adenocarcinoma. 4. Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment. 5. Able to swallow tablets. 6. ECOG Performance Status of 0-1. 7. No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy. 9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the anal verge Exclusion Criteria: 1. Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen. 2. Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments. 4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone marrow transplantation. 6.Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI). 7.Severe infection within 4 weeks or active pulmonary i…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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