Actively Recruiting

Phase 2
Age: 18Years - 70Years
All Genders
NCT05515315

Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

Led by Fuzhou General Hospital · Updated on 2024-02-07

93

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To explore the efficacy of Tislelizumab combined with chemotherapy in the treatment of locally unresectable esophageal squamous cell carcinoma (ESCC)

CONDITIONS

Official Title

Induction Tislelizumab Combined With Chemotherapy Followed by Definitive Chemoradiotherapy in the Treatment of Locally Unresectable Esophageal Squamous Cell Carcinoma

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed localized esophageal squamous cell carcinoma (ESCC) suitable for chemoradiotherapy, including stage II-IVA inoperable ESCC
  • Age between 18 and 70 years, any gender
  • ECOG performance status score of 0 or 1
  • Presence of measurable or non-measurable lesions according to RECIST 1.1
  • Adequate organ and bone marrow function with specific blood count and biochemistry levels
  • Expected survival time longer than 6 months
  • Fertile participants must agree to use medically approved contraception during treatment and for 3 months after last treatment
  • Voluntary participation with signed informed consent form
Not Eligible

You will not qualify if you...

  • History of fistula caused by primary tumor invasion
  • Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage within 2 weeks before randomization
  • Known intolerance or resistance to chemotherapy drugs used in this study
  • Previous antitumor therapy for ESCC including immunotherapy, radiotherapy, targeted therapy, ablation, or other systemic/local treatments
  • Active or history of autoimmune disease that may relapse, or history of allogeneic organ or hematopoietic stem cell transplantation
  • History of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases including pulmonary fibrosis and acute lung disease
  • Severe chronic or active infections requiring systemic antimicrobial, antifungal, or antiviral therapy prior to enrollment
  • Known HIV infection
  • Other malignancies within the past 5 years except certain skin and in situ carcinomas
  • Received live vaccine within 28 days before enrollment
  • Currently participating in another therapeutic clinical trial

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

Ye zai sheng

Fuzhou, Fujian, China, 350500

Actively Recruiting

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Research Team

F

Fu zhi chao, Doctor of Medicine

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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