NCT07196345

TAS-102 Plus Radiotherapy in Elderly ESCC

Efficacy and Safety of Trifluridine/Tipiracil Combined With Radiotherapy in Elderly Patients With Locally Advanced Esophageal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, multicenter clinical trial evaluating the efficacy and safety of radiotherapy combined with TAS-102 monotherapy in elderly patients with locally advanced esophageal cancer. Treatment Phase: The treatment phase is divided into a Phase I stage and a Phase II stage. The Phase I stage aims to explore the maximum tolerated dose (MTD) of TAS-102 in elderly esophageal cancer patients. A total of 9 subjects were enrolled, and the dose was escalated from 30 mg/m² in 5 mg/m² increments up to 40 mg/m². The MTD was defined as the highest drug dose at which no dose-limiting toxicity (DLT) was observed in more than 40% of treated patients during the first two weeks of combined radiotherapy and TAS-102 administration. The Phase II stage aims to investigate the efficacy of radiotherapy combined with TAS-102 at the MTD in elderly esophageal cancer patients, with 36 subjects enrolled. Consolidation Phase: Following the treatment phase, subjects had a 3-4 week rest period. This was followed by consolidation therapy with TAS-102 monotherapy at a dose of 35 mg/m², administered twice daily on days 1-5 of a 28-day cycle for two cycles. Subsequently, patients entered the efficacy and safety follow-up phase until the study endpoints were reached or after a full 2-year follow-up period.

Conditions

• ESCC
• TAS 102
• Radiotherapy

Interventions

Type	Name	Description
DRUG	TAS-102	Administered orally at 35 mg/m²/dose twice daily (morning and evening), in a bi-weekly regimen on Days 1-5.
RADIATION	Radiotherapy	Total dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved.

Timeline

• Start date: 2025-09-25
• Primary completion: 2027-09-25
• Completion: 2028-12-31
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

1 site across 1 country: China