Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Esophageal Squamous Cell Carcinoma (ESCC)Locally Advanced Unresectable Esophageal Cancer
Interventions
DRUG

Tislelizumab

"1. ICRT phase -Tislelizumab and CRT regimen Tislelizumab 200 mg IV, C1D1 and C4D1~2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )~3. Adjuvant phase-Tislelizumab Tislelizumab 200 mg IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of one year or 17 cycles.)"

DRUG

Paclitaxel

"1. ICRT phase -Tislelizumab and CRT regimen Paclitaxel 50 mg/m2 IV, D1, weekly (\* 4-6 cycles judged by investigators.)~2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Paclitaxel 135 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles.)"

DRUG

Cisplatin

"1. ICRT phase -Tislelizumab and CRT regimen Cisplatin 25 mg/m2 IV, D1, weekly ( 4-6 cycles judged by investigators.)~2. Consolidation phase: Tislelizumab-Paclitaxel-Cisplatin regimen Cisplatin 75 mg/m2 IV, D1, every 3 weeks (\*The regimen is repeated until unacceptable toxicity or disease progression, up to maximum of 2 cycles. )"

RADIATION

Radiation Therapy

1\. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase.

Trial Locations (4)

404

China Medical University Hospital, Taichung

Unknown

Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

National Cheng Kung University Hospital, Tainan City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BeiGene

INDUSTRY

lead

Ming-Yu Lien

OTHER

NCT07039162 - Study of Tislelizumab Combined With Chemoradiotherapy and Surgery for Unresectable Esophageal Squamous Cell Carcinoma | Biotech Hunter | Biotech Hunter