Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Tislelizumab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement
Condition(s) studied
Investigational drug(s) / intervention(s)
Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy: 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 summary
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.
Eligibility
Primary outcome measure(s)
- Complete response (CR) rate — At surgery, or at the confirmatory organ-preservation assessment approximately 12-16 weeks after the start of neoadjuvant therapy.
The complete response (CR) rate is defined as the proportion of all evaluable participants who achieve either a pathological complete response (pCR) or a clinical complete response (cCR). A participant is classified as a responder if they achieve pCR (defined as no residual tumour on postoperative pathology, ypT0N0) for patients undergoing surgical resection, or confirmed cCR (defined as no clinical, endoscopic, or radiological evidence of residual tumour) for patients managed with organ preservation without resection. These two response categories are mutually exclusive, and the CR rate is calculated using a single shared denominator consisting of all evaluable participants.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Shantou University Medical College Cancer Hospital | Shantou | Guangdong | Recruiting |
| The First Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | Not Yet Recruiting |
More Affiliated Cancer Hospital of Shantou University Medical College trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07104604 on ClinicalTrials.gov ↗ ← All trials in China