Status:
NOT_YET_RECRUITING
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC
Lead Sponsor:
Shanghai Zhongshan Hospital
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the effectiveness and safety of combining moderately hypofractionated radiotherapy with chemotherapy and anti-PD-1 antibodies as a neoadjuvant treatment for high-risk local...
Detailed Description
This study investigates a novel treatment approach involving moderately hypofractionated radiotherapy (3-3.5Gy×10) combined with chemotherapy and immunotherapy for patients with high-risk locally adva...
Eligibility Criteria
Inclusion
- Age ≥18 and ≤75 years.
- MRI-confirmed rectal adenocarcinoma with the lower edge of the lesion ≤10cm from the anal verge.
- Immunohistochemistry confirms proficiency in DNA mismatch repair (pMMR), or genetic testing confirms microsatellite instability-low (MSI-L) or microsatellite stable (MSS) status.
- Pelvic MRI showing one of the following high-risk factors: cT4a/b; N2; extramural vascular invasion (EMVI+); mesorectal fascia involvement (MRF+); enlarged lateral lymph nodes.
- ECOG performance status of 0-1.
- No prior surgery, radiotherapy, chemotherapy, or targeted therapy.
- Tolerable to radiotherapy, chemotherapy, and immunotherapy with laboratory results: WBC ≥4.0 × 10\^9/L, platelets ≥100 × 10\^9/L, hemoglobin ≥80g/L, ALT \<2ULN, TB \<35μmol/L, Scr \<1.5ULN or creatinine clearance rate ≥50mL/min, TSH ≤ULN (if abnormal, consider T3 and T4 levels; if T3 and T4 are normal, patients can still be included).
- Voluntary participation with signed informed consent.
Exclusion
- Distant metastases.
- Stage I or II rectal cancer not requiring neoadjuvant therapy.
- Severe cardiovascular, pulmonary, neurological, renal, gastrointestinal, or systemic diseases.
- Untreated chronic hepatitis B carrier with HBV DNA \>500 IU/ml, HCV RNA positive patients, except for inactive hepatitis B surface antigen carriers, stable hepatitis B (HBV DNA \<500 IU/ml), and cured hepatitis C patients.
- History of active autoimmune diseases or potential relapse of autoimmune diseases.
- Patients who received corticosteroids (equivalent to prednisone \>10mg/day) or other immunosuppressive therapy within 2 weeks prior to study drug administration.
- History of thyroid dysfunction.
- Severe chronic or active infections requiring systemic antifungal or antiviral therapy, including tuberculosis.
- Known allergy or hypersensitivity to multiple drugs.
- History of pelvic radiation.
- History of inflammatory bowel disease.
- Unwillingness to participate or sign informed consent.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2029
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06599827
Start Date
September 20 2024
End Date
September 20 2029
Last Update
September 19 2024
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200030