Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06964568

CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

Led by Fudan University · Updated on 2026-04-17

452

Participants Needed

1

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.

CONDITIONS

Official Title

CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent
  • Age 18 years or older
  • Histologically confirmed esophageal squamous cell carcinoma
  • Clinical stage T3-4N0M0 or TxN+M0 or TxNxM1 (only for supraclavicular lymph nodes) per 8th UICC-TNM classification
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy of at least 3 months
  • Adequate organ function including: absolute neutrophil count 651.5 �D7 10^9/L; hemoglobin 659 g/dl; platelets 65100 �D7 10^9/L; total bilirubin 651.5 times upper limit of normal (ULN); AST and ALT 652.5 ULN; creatinine 651.5 ULN
Not Eligible

You will not qualify if you...

  • Esophageal perforation or hematemesis
  • Active or history of autoimmune disease requiring immunosuppressive or systemic hormonal therapy within 28 days (except for chemoradiotherapy adverse events)
  • Previous or current PD-1/PD-L1 immunotherapy
  • Allergy to components of PD-1 inhibitors
  • Uncontrolled heart disease or symptoms including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or significant arrhythmia
  • Congenital or acquired immunodeficiency, active hepatitis B or C, or active tuberculosis
  • Active infection or unexplained fever above 38.5 0C within 2 weeks before randomization (unless tumor-related)
  • Fertility unwilling to use contraception during the trial, pregnancy, or breastfeeding
  • Other serious diseases or social factors that may affect safety or data collection as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

K

Kuaile Zhao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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