Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy… (NCT06599827) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC
China54 participantsStarted 2024-09-20
Plain-language 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 locally advanced rectal cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.