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OncoMatch/Clinical Trials/NCT05965531

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

Is NCT05965531 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trifluridine/Tipiracil for rectal cancer.

Phase 2RecruitingSun Yat-sen UniversityNCT05965531Data as of May 2026

Treatment: Trifluridine/TipiracilThe 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.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage T3-4N0M0, T1-4N1-2M0

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: rectal surgery

Cannot have received: pelvic radiotherapy

Cannot have received: chemotherapy

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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