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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Administered orally at 35 mg/m²/dose twice daily (morning and evening), in a bi-weekly regimen on Days 1-5.
Total dose of 50-60 Gy, delivered in 25-28 fractions, administered Monday through Friday (daily) until the full prescribed dose is achieved.
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
2-years OS rate
The percentage of study participants who are still alive at 2 years after the starting date of the study drug, calculated from the starting date of the study drug to the date of death from any cause.
Time frame: Approximately 24 months after the last subject participating in
ORR
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
Time frame: Approximately 4 months after the last subject participating in
PFS
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
Time frame: Approximately 12 months after the last subject participating in
Adverse Event (AE)
Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event.
Time frame: Up to approximately 2 years
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