Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT05833594

Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma

Led by Anhui Provincial Hospital · Updated on 2023-12-26

70

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Chemoradiotherapy has been a standard modality for inoperable locally advance esophageal carcinoma. The goal of this randomized control study is to compare the feasibility, and survival benefits of whole-course immunonutrition combined with chemoradiotherapy±ICIs for local advanced patients with inoperable esophageal squamous cell carcinoma. The main questions it aims to answer are: • If the feasibility and safety of whole-course immunonutrition combined with chemoradiotherapy±ICIs is better. • If the survival benefits (1, 2 and 3-years progression free survival) of whole-course immunonutrition combined with chemoradiotherapy±ICIs is longer. The Experimental group will receive a combination immunonutrition of omega-3 fatty acids, and glutamine, whereas the control group will receive standard formula.

CONDITIONS

Official Title

Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 85 years old
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Diagnosis of esophageal squamous cell carcinoma
  • Tumor stage cT2-4aN0-3M0 confirmed by radiological examination according to AJCC 8th edition
  • Cancer considered unresectable at initial diagnosis by thoracic surgeons
  • No prior treatment for esophageal cancer
  • No contraindications for adjuvant chemoradiotherapy
  • Signed informed consent provided
Not Eligible

You will not qualify if you...

  • Age younger than 18 years or older than 85 years
  • Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
  • Esophageal adenocarcinoma, small-cell cancer, or other pathological types besides squamous cell carcinoma
  • Tumor stages cT1anyNM0, cT4banyNM0, or any cTanyNM0 not meeting inclusion criteria
  • Cancer considered resectable at initial diagnosis by thoracic surgeons
  • Previous chemotherapy, radiotherapy, or other cancer treatments
  • Contraindications for chemoradiotherapy
  • No signed informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Anhui provincial hospital

Hefei, China

Actively Recruiting

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Research Team

D

dong qian, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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