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Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

NCT06601309 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Fujian Medical University Union Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-11
Primary Completion
2026-07-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06601309 on ClinicalTrials.gov