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 (Jun 2026). This Phase 1 trial studies Liposomal Irinotecan for rectal cancer.
Treatment: Liposomal Irinotecan — The 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT07104604 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages