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

December 20, 2023 updated by: Anhui Provincial Hospital

Anhui Provincial Hospita

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hefei, China
        • Recruiting
        • Anhui Provincial Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

  • 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
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.
Comparator
Whole-course nutrition Combined With Chemoradiotherapy±ICIs
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse events
Time Frame: 1 month post treatment
Rate of adverse events (CTCAE V4.0)
1 month post treatment
Disease Control Rate
Time Frame: 1 month post treatment
Disease Control Rate
1 month post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-, 2-, 3-year Progression-free survival rate (PFS).
Time Frame: 1 to 3 years
1-, 2-, 3-year Progression-free survival rate (PFS).
1 to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anhui Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023WCIN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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