Actively Recruiting
Adebrelimab Injection Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer
Led by Feng Tian · Updated on 2025-01-09
31
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining adebelimab with short course radiotherapy and CAPOX chemotherapy as a preoperative treatment for patients with locally advanced rectal cancer. This multicenter, single arm, prospective Phase 2 study focuses on patients with tumors meeting specific staging and operability criteria who have not received prior anti-tumor treatments. The goal is to assess how well this combination works before surgery and its safety profile. Participants will receive short course radiotherapy (5 sessions of 5 Gy each), followed by adebelimab injections given intravenously at a dose of 1200 mg or 20 mg/kg on the first day of each chemotherapy cycle. Chemotherapy includes oxaliplatin and capecitabine administered over six 3-week cycles. After completing chemotherapy, participants will undergo total mesorectal excision (TME) surgery 2 to 3 weeks later. If surgery is delayed due to adverse reactions or other reasons, researchers will adjust based on the patient's condition. Throughout the study, participants will be monitored with imaging and colonoscopy exams to evaluate tumor response. Laboratory tests will assess organ function and safety. The primary outcome is the pathological complete remission rate measured from enrollment through surgery over about six months. Secondary outcomes include tumor response rates, surgical success, and adverse reaction rates. Study visits, assessments, and safety monitoring will continue through surgery and up to 90 days after final treatment, with total participation lasting several months.
CONDITIONS
Brief 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 experimental procedures
- Male or female, aged 18 to 85 years
- Diagnosed with rectal adenocarcinoma by biopsy and histopathology
- Tumor stage cT3 or higher, or lymph node involvement, or specific imaging findings indicating operable locally advanced disease
- Tumor located within 15 cm of the anal edge
- At least one measurable lesion on imaging according to RECIST 1.1
- No prior anti-tumor treatment including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- ECOG performance status 0-1
- Adequate organ function meeting specified laboratory values
- Negative pregnancy test for women of childbearing potential before first treatment
- Use of effective contraception during treatment and for 120 days after last study drug administration
You will not qualify if you...
- Other untreated malignant tumors within 5 years (excluding certain skin cancers)
- Presence of distant metastasis
- Participation in other clinical trials or use of investigational treatments within 4 weeks before study
- Prior treatment with PD-1, PD-L1, PD-L2 inhibitors or T cell receptor modulators
- Use of traditional Chinese patent medicines with anti-tumor effects within 2 weeks before study
- Active autoimmune disease requiring systemic treatment within 2 years
- Systemic corticosteroid or immunosuppressive therapy within 7 days before study start (physiological doses allowed)
- History of organ or stem cell transplantation
- Allergy to study drugs or chemotherapy components
- Unresolved toxicity from prior treatments
- Known HIV infection
- Active hepatitis B or C infection
- Live vaccine within 30 days before treatment
- Pregnant or breastfeeding women
- Serious uncontrolled systemic diseases including heart, lung, liver conditions, uncontrolled diabetes, infections, or psychiatric disorders
- Any condition that may interfere with study participation or results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants receive short-course radiotherapy consisting of 5 daily treatments of 5 Gy each before starting chemotherapy and immunotherapy.
5 daily visits (in-person)
Duration - Approximately 18 weeks
Participants receive immunotherapy with Adebrelimab Injection combined with chemotherapy using the CAPOX regimen repeated every 3 weeks for 6 cycles.
1 visit on day 1 of each chemotherapy cycle (6 visits total)
Duration - 2 to 3 weeks
Participants undergo total mesorectal excision (TME) surgery 2 to 3 weeks after completing chemotherapy and immunotherapy.
1 visit (in-person) for surgery
Duration - Up to 6 months
Participants are monitored for adverse reactions and assessed for treatment response up to 90 days after the last medication and up to 6 months after surgery.
Periodic visits over 6 months for assessments
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