Status:
RECRUITING
SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC
Lead Sponsor:
Ruijin Hospital
Conditions:
Rectal Cancer
Rectal Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (...
Eligibility Criteria
Inclusion
- Histopathologically confirmed rectal adenocarcinoma with no prior antitumor therapy.
- Exclusion of patients with BRAF mutations or MSI-H status, as determined by pre-enrollment genetic testing including RAS, BRAF, and MSI analysis. RAS mutation status is permitted regardless.
- Absence of severe intestinal obstruction symptoms and no evidence of distant metastasis confirmed by imaging examinations such as CT, MRI, or PET/CT.
- Confirmation as locally advanced rectal cancer by rectal MRI, meeting one or more of the following criteria: T3c-d or T4, N2, EMVI(+), MRF(+), lateral lymph node metastasis; or patients with low-lying rectal cancer (≤5 cm from the anal verge) unsuitable for sphincter-preserving surgery prior to neoadjuvant therapy.
- Age 18 to 75 years.
- ECOG Performance Status of 0 to 1, without severe comorbid medical conditions.
- Adequate organ function:
- Hematopoietic: Hemoglobin ≥90 g/L, Platelets ≥80 × 10\^9/L, Absolute Neutrophil Count ≥1.5 × 10\^9/L.
- Hepatic: ALT and AST \< 2.5 × ULN. Renal: Serum Creatinine \< 1.5 × ULN.
- Provision of signed and dated written informed consent.
Exclusion
- Patients found to have BRAF mutations or MSI-H status.
- Patients who have previously received chemotherapy, radiotherapy, immunotherapy, targeted therapy, or surgical resection for colorectal cancer prior to enrollment.
- History or presence of another malignancy (except for early-stage basal cell carcinoma or carcinoma in situ of the cervix) within the past 3 years, with the disease not under control.
- Patients who are pregnant (confirmed by serum or urine β-HCG test) or breastfeeding.
- Patients with severe cardiac, hepatic, renal, neurological, or psychiatric diseases.
- Patients with active infections.
- Poor overall health status, with an ECOG performance status ≥2.
- Patients who have undergone organ transplantation requiring immunosuppressive therapy, or those requiring long-term corticosteroid treatment for autoimmune diseases.
- Patients with comorbid conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the completion of the study.
- Known hypersensitivity to any of the study drugs.
Key Trial Info
Start Date :
September 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT07198165
Start Date
September 5 2025
End Date
December 31 2030
Last Update
September 30 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China