Sequential Tegafur-gimeracil-oteracil Potassium Capsule (s-1) and Serplulimab Following Concurrent Chemoradiotherapy for Esophageal Squamous Cell Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

May 20, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

April 30, 2026

Conditions
Locally Advanced Inoperable Esophageal Squamous Cell Carcinoma
Interventions
DRUG

Serplulimab

Serplulimab will be administered as a fixed dose of 300 mg via intravenous infusion every three weeks, continuing for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent

DRUG

Tegafur-gimeracil-oteracil potassium capsule(S1)

S1 will be administered at a dose of 60 mg/m2 per day, taken orally in two divided doses on day 1 concurrent with radiotherapy, repeated every 28 days; and from day 1 to day 14 of each 21-day cycle, for up to 12 months or until disease progression, unacceptable toxicity, or withdrawal of consent

RADIATION

Radiotherapy

Radiotherapy will be delivered as a total dose of 50.4 Gy in 28 fractions over six weeks using techniques such as IGRT, IMRT, VMAT, or TOMO, targeting the primary tumor and associated lymph nodes

DRUG

Cisplatin

Cisplatin will be administered at a dose of 75 mg/m\^2 on day 1 concurrent with radiotherapy, repeated every 28 days

Trial Locations (1)

310022

RECRUITING

Zhejiang Cancer Hospital, Hangzhou

All Listed Sponsors
lead

Zhejiang Cancer Hospital

OTHER