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

Recruiting

• Conditions: Inoperable; Chemoradiotherapy; Esophageal Squamous Cell Carcinoma; Immunonutrition
• Interventions: Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

• Registration Number: NCT05833594
• Lead Sponsor: Anhui Provincial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-04-16
• Study First Posted: 2023-04-27
• Study Start: 2023-07-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-26
• Primary Completion: 2026-01-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs	Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Comparator	Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs	Whole-course nutrition Combined With Chemoradiotherapy±ICIs

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
1-, 2-, 3-year Progression-free survival rate (PFS).	1 to 3 years	1-, 2-, 3-year Progression-free survival rate (PFS).

Trial Locations

Locations (1)

Anhui provincial hospital; 🇨🇳 Hefei, China