Actively Recruiting
Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-04-18
80
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance tolerability, and improve prognosis in patients with locally advanced, microsatellite-stable (MSS) rectal cancer. The main questions it aims to answer are: Does this TNT approach improve complete response (CR) rates? How does selective reduction of clinical target volume (CTV) to S2/S3 level compare with conventional CTV irradiation in terms of efficacy and safety? Researchers will compare a selective CTV reduction group and a conventional CTV irradiation group to assess differences in treatment outcomes, including complete response, tumor regression grading (TRG), organ preservation, R0 resection rates, and long-term survival. Participants will: Receive long-course chemoradiotherapy with either conventional or reduced CTV irradiation. Undergo sequential chemotherapy. Receive PD-1 inhibitor treatment. Be monitored for safety, tumor regression, and long-term survival outcomes.
CONDITIONS
Official Title
Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signs a written informed consent form.
- Aged between 18 and 75 years at enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival of more than 2 years.
- Histologically confirmed rectal adenocarcinoma.
- Tumor biopsy immunohistochemistry indicating pMMR (MSH1, MSH2, MSH6, and PMS2 all positive) or genetic testing confirming MSS.
- Clinical staging as cT3-4NanyM0 or cTxN+M0 (stage II-III rectal cancer) confirmed by high-resolution MRI endorectal ultrasound.
- Tumor located below the peritoneal reflection without lateral lymph node metastasis.
- Eligible for R0 resection with curative intent as evaluated by a surgical attending physician.
- No prior systemic or local anti-tumor treatment for rectal cancer.
- Willing to provide tumor tissue and peripheral blood samples for research during screening and study.
- Adequate organ function including hematology, renal, liver, coagulation, and cardiac parameters as specified.
- Female participants of childbearing potential must have a negative pregnancy test within 3 days before treatment and agree to use highly effective contraception until 120 days after last dose.
- Willing and able to comply with study visit schedules, treatment plans, laboratory tests, and other study-related requirements.
You will not qualify if you...
- Presence of suspected metastatic lesions or locally advanced unresectable disease.
- Diagnosis of other malignancies within past 5 years except certain locally cured cancers.
- Concurrent enrollment in other clinical studies unless observational or follow-up phase.
- Intestinal obstruction, perforation, or bleeding requiring emergency surgery.
- Multiple primary rectal cancers.
- History of pelvic or abdominal radiotherapy.
- Inability to swallow tablets or conditions affecting gastrointestinal absorption.
- Prior systemic or local anti-tumor treatment for locally advanced rectal cancer.
- Use of nonspecific immunomodulatory treatments within 2 weeks before study treatment.
- Active autoimmune disease requiring systemic treatment in past 2 years except replacement therapy.
- History of pneumonitis requiring systemic glucocorticoid therapy or interstitial lung disease.
- Severe bleeding disorders or long-term anticoagulation therapy.
- Uncontrolled comorbidities limiting compliance.
- Recent cardiac conditions or hospitalizations within 12 months.
- History of inflammatory bowel disease.
- Severe infections within 4 weeks or active infections requiring systemic therapy within 10 days before study.
- Major surgery or severe trauma within 30 days before study treatment.
- Immunodeficiency, positive HIV test, or long-term corticosteroid/immunosuppressant use.
- Active tuberculosis or syphilis requiring clinical exclusion.
- History of organ or stem cell transplantation.
- Untreated active HBV or HCV infection.
- Live vaccine administration within 30 days before or planned during study.
- Known hypersensitivity to study drugs or severe monoclonal antibody reactions.
- Psychiatric disorders, substance abuse, alcohol dependence, or drug addiction.
- Pregnant or breastfeeding women.
- Any condition that may interfere with study participation or affect results.
- Non-malignant diseases causing high medical risk or uncertainty in survival assessment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Actively Recruiting
Research Team
Y
Yanxin Luo, M.D., Ph.D.
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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