Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy

The goal of this Phase 2 trial is to evaluate a neoadjuvant treatment mode for locally advanced rectal cancer (LARC), consisting of radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). The main questions it aims to answer are: (i) whether TAS-102 is effective in treating LARC, when combined with radiotherapy; (ii) whether TAS-102 is safe in combination with radiotherapy. Participants will receive one cycle of TAS-102 chemotherapy and neoadjuvant radiotherapy based on intensity-modulated technique. Then the ones with a possibility of R0 resection will receive radical surgery followed b

Trial Details

NCT ID
NCT05965531
Phase
PHASE2
Sponsor
Sun Yat-sen University
Status
RECRUITING
Cancer Type
Colorectal Cancer
Interventions
  • Trifluridine/Tipiracil
  • intensity-modulated radiotherapy
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

  • Pathologically diagnosed rectal adenocarcinoma via biopsy
  • Pretreatment clinical TNM stage as T3-4N0M0 or T1-4N1-2M0 (UICC TNM staging classification, version 8)
  • Tumor with proficient DNA mismatch repair confirmed by immunohistochemical analysis
  • Age between 18 and 75 years old

For full eligibility, visit ClinicalTrials.gov.

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