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RECRUITING
NCT06601309
PHASE2

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the impact of the neoadjuvant treatment strategy based on CPS score on the pathological complete response (pCR) rate in patients with resectable locally advanced esophageal cancer.

Official title: Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: an Exploratory Phase II Single-arm Clinical Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-07-11

Completion Date

2026-12-01

Last Updated

2025-09-15

Healthy Volunteers

No

Interventions

DRUG

Serplulimab

Serplulimab (300 mg) administered intravenously on day 1 of each 21-day cycle for 2 cycles.

DRUG

Paclitaxel+Cisplatin (Neoadjuvant Chemotherapy)

Paclitaxel (175 mg/m²) and Cisplatin (75 mg/m²) administered intravenously on day 1 of each 21-day cycle for 2 cycles as part of neoadjuvant chemotherapy.

DRUG

Paclitaxel+Cisplatin(Concurrent Chemoradiotherapy)

Paclitaxel (50 mg/m²) and Cisplatin (25 mg/m²) administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle as part of concurrent chemoradiotherapy.

RADIATION

Radiotherapy

Radiotherapy at a dose of 40 Gy, delivered in 20 fractions over 4 weeks.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China