Actively Recruiting
Adebrelimab Injection Combined With Short Course Radiotherapy and Chemotherapy for Pre-Surgery Treatment of Locally Advanced Rectal Cancer A Multicenter, Single Arm Prospective Study
Led by Feng Tian · Updated on 2025-01-09
31
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment involving adebrelimab, short course radiotherapy, and chemotherapy as a preoperative therapy for patients with locally advanced rectal cancer. This multicenter, single-arm, prospective phase 2 study focuses on patients diagnosed with rectal adenocarcinoma who meet specific clinical and imaging criteria indicating the need for neoadjuvant therapy before surgery. Participants receive a combination of adebrelimab injection, short course radiotherapy of 5 sessions at 5Gy each, and CAPOX chemotherapy which includes oxaliplatin and capecitabine over 6 cycles every 3 weeks. Surgery using total mesorectal excision (TME) is planned 2 to 3 weeks after completing the last chemotherapy cycle. Adjustments to surgery timing may be made based on clinical circumstances such as delayed side effects. During the study, participants will undergo assessments including imaging and biopsies to evaluate tumor response. Researchers will monitor safety and efficacy, with the primary outcome being the rate of complete tumor remission assessed from enrollment until surgery, up to 6 months. Participants are closely followed through laboratory tests, physical exams, and monitoring for adverse effects throughout treatment and surgery periods.
CONDITIONS
Official Title
Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Male or female aged 18 to 85 years
- Diagnosed with rectal adenocarcinoma by biopsy and histopathology
- Clinical tumor stage T3 or higher, or lymph node involvement N1+, no distant metastasis, or specific imaging findings indicating operable locally advanced disease
- Tumor located 15cm or less from the anal edge by imaging and colonoscopy
- At least one measurable tumor lesion on imaging per RECIST 1.1 criteria
- No prior anti-tumor treatments including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- ECOG performance status score of 0 or 1
- Adequate organ function meeting specified laboratory criteria (neutrophils, platelets, hemoglobin, liver enzymes, kidney function, coagulation, thyroid function, myocardial enzymes)
- Negative pregnancy test for women of childbearing potential within 3 days before first study drug dose
- Use of effective contraception during treatment and up to 120 days after last study drug dose (180 days after last chemotherapy)
You will not qualify if you...
- Other malignant tumors not cured within 5 years before first dose (except certain skin cancers)
- Late-stage rectal cancer with distant metastasis
- Participation in other interventional clinical trials or use of investigational drugs/devices within 4 weeks prior to first dose
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or T-cell modulating drugs
- Use of systemic traditional Chinese anti-tumor or immunomodulatory medicines within 2 weeks before first dose
- Active autoimmune disease requiring systemic treatment within 2 years before first dose
- Systemic corticosteroid or immunosuppressive therapy within 7 days before first dose (physiological doses allowed)
- History of allogeneic organ or stem cell transplantation (excluding corneal)
- Allergies to adebrelimab or chemotherapy components
- Incomplete recovery from prior treatment toxicities above grade 1 (except fatigue or hair loss)
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccine administration within 30 days before first dose
- Pregnant or breastfeeding women
- Serious or uncontrolled systemic diseases including significant heart abnormalities, unstable angina, recent myocardial infarction, poor blood pressure control, recent pneumonia requiring steroids, active lung disease, active infections, gastrointestinal complications, liver disease, poorly controlled diabetes, significant proteinuria, or mental disorders preventing cooperation
- Any medical condition or laboratory abnormality interfering with study participation or results as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250021
Actively Recruiting
Research Team
F
Feng Tian, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here