OncoMatch/Clinical Trials/NCT05965531
Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
Is NCT05965531 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Trifluridine/Tipiracil for rectal cancer.
Treatment: Trifluridine/Tipiracil — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3-4N0M0, T1-4N1-2M0
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT05965531 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage T3-4N0M0 or T1-4N1-2M0 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages