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

Sponsor
Affiliated Cancer Hospital of Shantou University Medical College
Study ID
NCT07104604
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liposomal Irinotecan — DRUG
    In this study, the novel drug liposomal irinotecan was added, replacing the conventional formulation of irinotecan, and used as an intensified chemotherapy regimen (liposomal irinotecan + capecitabine) combined with immunotherapy and radiotherapy for neoadjuvant treatment of mid-lower rectal cancer.

Study Details

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.

Key Dates

Start date
Aug 1, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
59 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal Irinotecan
    Treatment regimen: 1. During radiotherapy: Radiotherapy 50Gy/25F + liposomal irinotecan 30mg/m² ivgtt qw w1-w4 + capecitabine 625mg/m² Bid, orally on radiotherapy days + tislelizumab 200mg ivgtt q3w; 2. Radiotherapy-surgery interval: Liposomal irinotecan 70mg/m² ivgtt q3w + capecitabine 1000mg/m² Bid D1-D14 q3w + tislelizumab 200mg ivgtt q3w.

Primary Outcome Measure

Complete remission rate [ Time Frame: 24 months ]

Central Contacts

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