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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Anhui Provincial Hospita

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05833594
• Other study ID #: 2023WCIN001
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: December 2023
• Source: Anhui Provincial Hospital
• Contact: dong qian, M.D.
• Phone: +86-19156007756
• Email: qiankeyu1983[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Chemoradiotherapy
• Esophageal Squamous Cell Carcinoma
• Immunonutrition
• Inoperable

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
China	Anhui provincial hospital	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of adverse events	Rate of adverse events (CTCAE V4.0)	1 month post treatment
Primary	Disease Control Rate	Disease Control Rate	1 month post treatment
Secondary	1-, 2-, 3-year Progression-free survival rate (PFS).	1-, 2-, 3-year Progression-free survival rate (PFS).	1 to 3 years