Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06601309

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Led by Fujian Medical University Union Hospital · Updated on 2025-09-15

90

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Biomarker Based Neoadjuvant Strategies for Locally Advanced Resectable ESCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed esophageal squamous cell carcinoma (ESCC)
  • Resectable locally advanced ESCC (clinical stage II-III per AJCC/UICC 8th edition)
  • Age between 18 and 75 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Available PD-L1 expression level (CPS)
  • Eligible for surgical resection as assessed by a thoracic surgeon
  • Adequate bone marrow function: Absolute neutrophil count  1.5 x 10^9/L, Platelets  100 x 10^9/L, Hemoglobin  9 g/dL
  • Adequate liver function: Total bilirubin  1.5 x upper limit of normal (ULN), AST and ALT  2.5 x ULN
  • Adequate renal function: Serum creatinine  1.5 x ULN or creatinine clearance  60 mL/min
  • Ability to understand and willingness to sign written informed consent
Not Eligible

You will not qualify if you...

  • Presence of distant metastasis
  • History of other malignancies within past 5 years except treated carcinoma in situ of cervix, basal or squamous cell skin carcinoma, or localized non-invasive malignancy
  • History of active autoimmune diseases requiring systemic treatment within past 2 years
  • Active infection requiring systemic therapy
  • Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations limiting compliance
  • Previous treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies
  • Pregnant or breastfeeding women; women of childbearing potential must have negative serum pregnancy test within 7 days prior to randomization
  • Known allergy or hypersensitivity to study drugs or their excipients

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

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

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Research Team

Z

Zhao-han Lin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

3

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