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NOT YET RECRUITING
NCT07678580
PHASE2

Neoadjuvant Short-Course Radiotherapy Plus Tislelizumab and Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

Summary

Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Plus Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma This is a prospective, randomized, two-arm, parallel-group, multicenter, exploratory Phase II clinical trial. It aims to evaluate the efficacy and safety of neoadjuvant short-course radiotherapy followed by tislelizumab combined with chemotherapy in participants with locally advanced resectable esophageal squamous cell carcinoma (ESCC). Eligible participants will be randomized in a 1:1 ratio to receive either low-dose or high-dose short-course radiotherapy, followed by tislelizumab, nab-paclitaxel, and carboplatin for 3 cycles. Surgery will be performed 4-6 weeks after the last neoadjuvant treatment. Primary endpoint: Pathological Complete Response (pCR) rate. Secondary endpoints: Major Pathological Response (MPR) rate, Objective Response Rate (ORR), R0 resection rate, downstaging rate, 3-year Event-Free Survival (EFS), 3-year Overall Survival (OS), safety profile, and quality of life. Approximately 50 participants will be enrolled. Randomization will be stratified by tumor location, clinical T stage, and clinical N stage using a stratified block design via an EDC/IWRS system.

Official title: Neoadjuvant Short-Course Radiotherapy Followed by Tislelizumab Combined With Chemotherapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: A Prospective, Multicenter, Exploratory Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-07-10

Completion Date

2029-06-30

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

DRUG

Albumin-bound paclitaxel

Albumin-bound paclitaxel at a dose of 125 mg/m² is administrated intravenously on day 1 and day 8 of each 3-week cycle, for a total of 3 cycles.

RADIATION

Low-dose Short-course Radiotherapy

Neoadjuvant short-course radiotherapy with a total dose of 10 Gy, delivered in 5 daily fractions of 2.0 Gy per fraction, administered consecutively before systemic combination therapy.

RADIATION

High-dose Short-course Radiotherapy

Neoadjuvant short-course radiotherapy with a total dose of 15 Gy, delivered in 5 daily fractions of 3.0 Gy per fraction, administered consecutively before systemic combination therapy.

DRUG

Tislelizumab Combined With Chemotherapy for 3 cycles

Anti-PD-1 monoclonal antibody tislelizumab 200 mg is given by intravenous infusion on day 1 of each 3-week cycle, for up to 3 cycles in the neoadjuvant treatment phase.

DRUG

Carboplatin (AUC 5)

Carboplatin is given intravenously on day 1 of each cycle at a targeted AUC of 5, repeated every 3 weeks for 3 cycles as part of neoadjuvant combination regimen.

Locations (1)

Tangdu Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China