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

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;

Trial Details

NCT ID
NCT07104604
Phase
PHASE2
Sponsor
Affiliated Cancer Hospital of Shantou University Medical College
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Liposomal Irinotecan+Tislelizumab+Capecitabine+Rradiotherapy
Locations (sample)
  • Shantou, Guangdong, China|23.35489,116.67876
  • Shantou, Guangdong, China|23.35489,116.67876

Key Eligibility Criteria

  • Age: 18-75 years, no gender restriction
  • ECOG score 0-1
  • Biopsy-confirmed pMMR (proficient mismatch repair) localized advanced low rectal adenocarcinoma (tumor's lower edge ≤ 10 cm from the anus)
  • Presence of the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to undergo sphincter-preserving surgery

For full eligibility, visit ClinicalTrials.gov.

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