drugset / Trial / NCT05965531

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

NCT05965531 ↗

Phase 2 Recruiting 65 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelTreatment

Summary

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 by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.

Timeline

Start
2024-01-01
Primary completion
2028-12-31
Completion
2028-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Trifluridine/Tipiracil Unknown 35 mg/m2 —

Indications