Actively Recruiting
SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC
Led by Shandong Provincial Hospital · Updated on 2025-12-16
208
Participants Needed
1
Research Sites
406 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5\*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.
CONDITIONS
Official Title
SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any study-related procedures
- Diagnosed with rectal adenocarcinoma by biopsy and histopathology
- CT stage T3 or higher, or lymph node involvement N1+, no distant metastasis (M0), or presence of EMVI, MRF involvement, or suspected lateral lymph node metastasis >5mm
- Tumor located 10 cm or less from the anal edge confirmed by imaging and colonoscopy
- Tumor mismatch repair/microsatellite instability status is MSS
- At least one measurable lesion by imaging according to RECIST 1.1 criteria
- No prior anti-tumor treatment including surgery, radiotherapy, chemotherapy, immunotherapy, or targeted therapy
- ECOG performance status of 0 or 1
- Adequate organ function with specified laboratory values for neutrophils, platelets, hemoglobin, liver enzymes, kidney function, coagulation, thyroid function, and myocardial enzymes
- Negative pregnancy test within 3 days before first study drug for women of childbearing potential; contraception required during treatment and for a specified period after last drug administration
- Women of non-reproductive potential defined by postmenopausal status or surgical sterilization
You will not qualify if you...
- History of other malignant tumors not cured within 5 years (except certain skin cancers and cancer in situ fully removed)
- Presence of distant metastasis from rectal cancer
- Participation in other interventional clinical trials or use of investigational drugs/instruments within 4 weeks before study start
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or T cell receptor modulating drugs
- Use of systemic Chinese patent medicine with anti-tumor effects or immunomodulatory drugs within 2 weeks prior
- Active autoimmune diseases requiring systemic treatment within 2 years
- Systemic glucocorticoid or immunosuppressive therapy within 14 days before first dose, except low-dose physiological steroids
- History of allogeneic organ or hematopoietic stem cell transplantation
- Allergy to Adebrelimab or chemotherapy components
- Unresolved toxicities from prior treatments above grade 1, except fatigue or hair loss
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Live vaccine received within 30 days before first dose
- Pregnant or breastfeeding women
- Serious or uncontrolled systemic diseases including certain heart conditions, lung diseases, infections, liver diseases, uncontrolled diabetes, significant proteinuria, and mental disorders
- History of uncontrolled epilepsy, CNS disease, or mental disorder affecting consent or compliance
- Other conditions deemed unsuitable by the investigator
AI-Screening
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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.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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