Actively Recruiting
SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy for HIgh-Risk pMMR/MSS Rectal Cancer
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-05-14
49
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.
CONDITIONS
Official Title
SCRT + mFOLFOX6 + PD-1 Antibody + Targeted Therapy for HIgh-Risk pMMR/MSS Rectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent must be provided before procedures related to the study.
- Age between 18 and 75 years.
- Confirmed diagnosis of pMMR/MSS rectal adenocarcinoma by histology or cytology; other types excluded.
- Tumor located 10 cm or less from the anal verge.
- Clinical stage with high-risk factors such as cT3Nx, positive extramural vascular invasion (EMVI), or cT4, with or without positive mesorectal fascia (MRF) or EMVI.
- No evidence of distant metastasis before treatment.
- No prior anti-cancer treatments including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
- ECOG performance status of 0 or 1.
- Peripheral blood counts and liver and kidney function within specified normal ranges tested within 15 days before treatment.
- No history of other malignancies; not pregnant or breastfeeding; effective contraception required during and for 6 months after the study.
You will not qualify if you...
- History of severe drug allergies including to platinum agents, 5-FU, leucovorin, and 5-HT3 receptor antagonists.
- Participation in other clinical trials within 4 weeks prior to enrollment.
- Previous treatment with anti-PD-1, PD-L1, PD-L2, CTLA-4, or other immune checkpoint therapies.
- Severe electrolyte imbalances.
- Active gastrointestinal diseases such as ulcers, ulcerative colitis, or tumors with active bleeding not yet treated; or gastrointestinal perforation not healed after surgery.
- History of arterial or deep vein thrombosis within 6 months; bleeding or bleeding tendency within 2 months; or current high-dose anticoagulation therapy.
- Pregnant or breastfeeding women, or women with positive pregnancy test before first dose; unwillingness to use contraception.
- Other active malignancies unless disease-free for more than 3 years or in situ cancers adequately treated.
- Severe heart conditions including ECG abnormalities, coronary artery disease, angina, recent myocardial infarction within 12 months, or heart failure NYHA Class II or higher.
- Active infections causing fever above 38°C.
- Uncontrolled hypercalcemia, hypertension, or diabetes.
- Severe lung diseases such as interstitial pneumonia, pulmonary fibrosis, or severe emphysema.
- Psychiatric disorders affecting treatment or history of central nervous system diseases.
- Severe complications like bowel obstruction, renal or hepatic insufficiency, cerebrovascular disorders.
- Any unresolved CTCAE Grade 2 or higher toxicity from prior treatments (except anemia, hair loss, and skin pigmentation).
- Any unstable medical condition affecting safety or study compliance.
- Investigator judgment deeming the patient unsuitable for trial participation.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510065
Actively Recruiting
Research Team
J
Jun Huang, PhD.
CONTACT
F
Fang He, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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