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NCT Number: NCT05833594

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

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.

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Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Chemoradiotherapy Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Immunonutrition Inoperable Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs

Dietary Supplement

The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.

Primary outcomes

  1. Rate of adverse events

    Time frame: 1 month post treatment

    Rate of adverse events (CTCAE V4.0)

  2. Disease Control Rate

    Time frame: 1 month post treatment

    Disease Control Rate

Secondary outcomes

  1. 1-, 2-, 3-year Progression-free survival rate (PFS).

    Time frame: 1 to 3 years

    1-, 2-, 3-year Progression-free survival rate (PFS).

Study contacts

Contact information is provided by the study sponsor or research team.

dong qian, M.D.

CONTACT

[email protected]

+86-19156007756

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

Anhui Provincial Hospita

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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