Actively Recruiting
Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
Led by fan li · Updated on 2025-04-10
100
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.
CONDITIONS
Official Title
Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Age 18-80 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
- Able to swallow tablets.
- ECOG Performance Status of 0-1.
- No prior treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy.
- Fit for surgery with no contraindications.
- Normal organ function.
- Tumor �3 cm from the anal verge.
You will not qualify if you...
- Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
- Previous or current use of immune checkpoint inhibitors or immune-related treatments.
- Active autoimmune diseases or history of significant autoimmune conditions.
- Immunodeficiency disorders or history of organ/bone marrow transplantation.
- Uncontrolled cardiovascular conditions (e.g., heart failure, unstable angina, recent MI).
- Severe infection within 4 weeks or active pulmonary infections.
- Active hepatitis B or C infection.
- Diagnosis of other malignancies within 5 years (except low-risk cancers).
- Pregnant or breastfeeding women.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Daping Hospital
Chongqing, Chongqing Municipality, China, 400000
Actively Recruiting
Research Team
F
Fan LI, PhD
CONTACT
H
Haode Shen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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