Actively Recruiting
Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-08-07
430
Participants Needed
1
Research Sites
347 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Most rectal cancers are microsatellite stable (MSS) or mismatch repair-proficient (pMMR) and respond poorly to PD-1 inhibitors. Radiotherapy can enhance tumor antigen release and improve responsiveness to PD-1 blockade in MSS/pMMR rectal cancer. Tumor-draining lymph nodes (TDLNs) are critical sites for anti-tumor immune activation, but radiation-induced damage and fibrosis may impair lymphatic drainage and immune responses. Previous studies have reported a remarkable pathologic complete response (pCR) rate of 77.8% using node-sparing radiotherapy in locally advanced rectal cancer. This study aims to evaluate whether node-sparing short-course radiotherapy followed by sequential chemotherapy and PD-1 blockade can improve complete response rate in the phase II part and event-free survival in phase III part, together with sphincter preservation, treatment tolerance, and prognosis in patients with mid-low pMMR/MSS rectal cancer.
CONDITIONS
Official Title
Node-Sparing Short-Course Radiotherapy Sequential Chemotherapy and PD-1 Inhibitor for Mid/Low pMMR/MSS Rectal Cancer (MODIFI-RC-II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily signs informed consent
- Age between 18 and 75 years at enrollment
- ECOG performance status of 0 or 1
- Expected survival longer than 2 years
- Histologically confirmed rectal adenocarcinoma
- Tumor biopsy shows proficient mismatch repair (pMMR) or microsatellite stability (MSS)
- Clinical stage T3-4N0M0 or TanyN+M0 located in mid-to-lower rectum
- Qualified surgical physician confirms eligibility for curative R0 resection
- No prior systemic or local anti-tumor treatment for rectal cancer
- Agrees to provide tumor tissue and blood samples for research
- Adequate organ function including hematologic, renal, hepatic, coagulation, and cardiac parameters
- Women of childbearing potential have negative pregnancy test and agree to use effective contraception
- Willing and able to comply with study visits and treatment plans
You will not qualify if you...
- Presence of suspected metastatic lesions or unresectable locally advanced disease
- History of other malignancies within 5 years except cured localized cancers
- Lesions staged as T1N0 or T2N0 suitable for less invasive surgery
- Acute conditions needing emergency surgery like bowel obstruction or bleeding
- Multiple primary rectal cancers occurring at the same time
- History of pelvic or abdominal radiotherapy
- Inability to swallow tablets or malabsorption syndrome
- Prior systemic or local anti-tumor therapy for locally advanced rectal cancer
- Use of nonspecific immunomodulators or herbal anti-tumor medicines shortly before treatment
- Active autoimmune disease requiring systemic treatment within past 2 years
- History or current interstitial lung disease needing corticosteroids
- Bleeding disorders or need for long-term anticoagulation
- Uncontrolled serious comorbidities or psychiatric/social conditions impacting participation
- Significant cardiac disease within 12 months before treatment
- Recent severe gastrointestinal conditions or events within 6 months
- Recent thromboembolic or cerebrovascular events within 6 months
- Recent acute exacerbation of COPD or uncontrolled hypertension
- Active or prior inflammatory bowel disease or chronic diarrhea
- Severe infections or systemic infections requiring therapy shortly before treatment
- Recent major surgery or trauma
- History of immunodeficiency or HIV positivity
- Active tuberculosis or syphilis not ruled out
- History of organ or stem cell transplantation
- Untreated active hepatitis B or C
- Recent live vaccination or planned live vaccination during study
- Known hypersensitivity to study drugs or monoclonal antibodies
- History of psychiatric disorders, substance abuse, alcoholism, or drug addiction
- Pregnant or breastfeeding women
- Any disease, treatment, or abnormal lab findings affecting study participation or safety
- Systemic or local disease caused by benign tumor or tumor-related complications posing high risk or survival uncertainty
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
Y
Yikan Cheng
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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