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

NCT05833594 · tracked via the Priya Life Science China tracker

Sponsor

Anhui Provincial Hospital

Phase

Observational

Started

2023-07-01

Last updated

2023-12-26

Condition(s) studied

Esophageal Squamous Cell CarcinomaChemoradiotherapyImmunonutritionInoperable

Investigational drug(s) / intervention(s)

Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs: The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * 18-85 years old; * Eastern Cooperative Oncology Group (ECOG) 0-2; * Esophageal squamous cell carcinoma; * cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination; * initial unresectable at initial diagnosis confirmed by thoracic surgeons; * Treatment naive; * No contraindications for adjuvant chemoradiotherapy; * Signature of inform consent. Exclusion Criteria: * younger than 18 years old or older than 85 years old; * ECOG\>2; * Esophageal adenocarcinoma, small-cell cancer and other pathological types; * cT1anyNM0, cT4banyNM0, c anyTanyNM0 confirmed by radiological examination; * Resectable at initial diagnosis confirmed by thoracic surgeons; * Previous treatment of chemotherapy, radiotherapy, and other treatment; * Contraindications for chemoradiotherapy; * No signature of inform consent.

Primary outcome measure(s)

Rate of adverse events — 1 month post treatment
Rate of adverse events (CTCAE V4.0)
Disease Control Rate — 1 month post treatment
Disease Control Rate

Trial sites (1)

Facility	City	Region	Status
Anhui provincial hospital	Hefei	China	Recruiting

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Other trials for the same condition

A Study to Compare the Efficacy and Safety of LY01015 and Opdivo® Combined Respectively With Chemotherapy in Advanced or Metastatic Esophageal Squamous Cell Carcinoma Active, not recruiting

Radiotherapy Target Volume Delineation in Locally Advanced Esophageal Cancer in the Immunotherapy Era Recruiting

Sintilimab After Concurrent Chemoradiotherapy in Elderly Patients With Esophageal Squamous Cell Carcinoma Recruiting

Nimotuzumab Concurrent With Chemoradiotherapy for Patients With Unresectable Esophageal Squamous Cell Carcinoma Recruiting

Watch and Wait for NeoAdjuvant Concurrent Radiochemotherapy Combined With Camrelizumab in Patients With Resectable ESCC Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05833594 on ClinicalTrials.gov ↗ ← All trials in China