Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

April 5, 2025

Primary Completion Date

April 4, 2029

Study Completion Date

April 4, 2029

Conditions
Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
DRUG

Induction chemoimmunotherapy

All patients will receive two cycles of induction therapy with albumin-bound paclitaxel and cisplatin combined with toripalimab.

RADIATION

Hypofractionated Radiation Therapy

"All patients will receive hypofractionated radiotherapy once daily, five days per week, followed by a boost. Three weeks after the completion of the first phase of hypofractionated radiotherapy, tumor response and cardiopulmonary function will be evaluated. For patients who achieve a partial response, have no deep esophageal ulcers on endoscopy, and have cardiopulmonary function tolerating the radiotherapy boost, a second phase of radiotherapy will be planned using a new CT simulation and radiotherapy design.~First Phase of Radiotherapy: Total dose of 2500 cGy in 5 fractions (500 cGy per fraction) Second Phase of Radiotherapy: Total dose of 2500 cGy in 10 fractions (250 cGy per fraction) The interval between the two phases of radiotherapy will be 28 days."

RADIATION

Conventional Fractionated Radiation Therapy

Patients will receive a total dose of 5000 cGy in 25 fractions, with 200 cGy per fraction.

DRUG

Concurrent Chemotherapy

Capecitabine oral administration, 1000 mg/m², twice daily

Trial Locations (1)

510060

RECRUITING

Sun yat-sen University Cancer Center, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER