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OncoMatch/Clinical Trials/NCT07104604

Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Toripalimab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement

Is NCT07104604 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Liposomal Irinotecan for rectal cancer.

Phase 1RecruitingAffiliated Cancer Hospital of Shantou University Medical CollegeNCT07104604Data as of May 2026

Treatment: Liposomal IrinotecanThe goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received:

Patients who participated in other clinical trials within 4 weeks before enrollment

Lab requirements

Blood counts

Neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 70 g/L

Kidney function

Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (Cockcroft-Gault)

Liver function

ALT, AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g/dL

Bone marrow function: Neutrophil count (ANC) ≥ 1.5 × 10^9/L, platelet count (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 70 g/L; Liver function: ALT, AST ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; serum albumin ≥ 3 g/dL; Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (Cockcroft-Gault)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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