Actively Recruiting
Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Led by West China Hospital · Updated on 2025-07-17
186
Participants Needed
1
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of the rectum (the long diameter of the tumor was shortened by ≥30% compared with that before treatment) were randomly divided into two groups. One group was long-course chemoradiotherapy combined with consolidation chemotherapy (TNT group). In the other group, long-term chemoradiotherapy combined with immunotherapy and consolidation chemotherapy (iTNT group), we explored whether TNT could achieve a higher organ preservation rate after effective neoadjuvant chemotherapy in patients with low and intermediate-risk low rectal cancer, and the organ preservation rate of TNT combined with immunotherapy.
CONDITIONS
Official Title
Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Any gender
- Diagnosis of rectal adenocarcinoma confirmed by pathology with pMMR/MSS status
- Tumor characteristics: tumor lower edge ≤5 cm from anal verge; clinical stage cT1-3abN0-1M0; MRF negative; lateral lymph nodes negative and <7 mm; tumor diameter ≤5 cm; tumor circumference ≤ 2/3
- ECOG performance status 0-1
- No prior surgery, radiotherapy, chemotherapy, or other anti-tumor treatments for primary rectal cancer
- Normal organ function based on blood counts and biochemical tests within specified limits
- No allergy history to 5-Fu or platinum drugs
- Women of childbearing age must have negative pregnancy test and agree to contraception during and 8 weeks after trial
- Men must agree to surgical sterilization or contraception during and 8 weeks after trial
- Voluntary participation with signed informed consent and ability to comply with follow-up
You will not qualify if you...
- Diagnosis of Lynch syndrome
- Distant metastasis detected during treatment
- Previous or concurrent other malignant tumors except cured basal cell carcinoma of skin or cervical carcinoma in situ
- Prior pelvic radiotherapy
- Pregnant or lactating women with fertility needs; male patients with fertility needs
- Uncontrolled systemic diseases including diabetes, hypertension, active or history of autoimmune diseases, severe heart, lung, kidney diseases
- Active hepatitis B or C infection
- Mental disorders
- Severe infection within 4 weeks before first dose or active pulmonary inflammation needing antibiotics within 2 weeks
- Bleeding disorders or use of thrombolytic/anticoagulant therapy; recent aneurysm, stroke, or arteriovenous malformation
- Serious gastrointestinal diseases affecting oral chemotherapy absorption or history of fistula, perforation, bleeding, or severe ulcer
- History of immunodeficiency, organ transplantation, or bone marrow transplantation
- History of interstitial lung disease, pulmonary fibrosis, active or recent pulmonary tuberculosis
- Allergy to macromolecular protein preparations, tislelizumab, etoposide, cisplatin, or their components
- Prior use of anti-PD-1/PD-L1 therapy, chemotherapy, radiotherapy, targeted therapy within 4 weeks
- Requirement for systemic corticosteroids (>10 mg prednisone daily) or other immunosuppressants within 2 weeks, except specific allowed uses
- Vaccination with antitumor or live vaccine within 4 weeks
- Enrollment in another clinical trial within 4 weeks before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
W
Wang Ziqiang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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