Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

79

Participants

Timeline

Start Date

August 1, 2024

Primary Completion Date

September 1, 2027

Study Completion Date

September 1, 2029

Conditions
Esophageal Squamous Cell Carcinoma (ESCC)
Interventions
DRUG

Sintilimab Combined With Docetaxel Monotherapy

79 patients will receive treatment with a PD-1 inhibitor (sintilimab or camrelizumab 200mg, d1, q3w) combined with monotherapy chemotherapy (paclitaxel 175mg/m2 or docetaxel 75mg/m2 or irinotecan 270mg/m2, d1, q3w) for 4 cycles, followed by a 2-year maintenance treatment with PD-1 inhibitors. During this period, patients diagnosed with esophageal wall thickening and identified as having progressive disease (PD) have the option to undergo salvage radiotherapy (45-50.4 Gy/25-28/F/5-5.5 weeks) in conjunction with a dual-agent chemotherapy (paclitaxel 50 mg/m2, d1 + carboplatin AUC 2, d1, qw) for 5 cycles.

Trial Locations (1)

210009

Jiangsu Provincial Cancer Hospital, Nanjing

All Listed Sponsors
lead

Ye jinjun

OTHER