- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05833594
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
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
- Name: dong qian, M.D.
- Phone Number: +86-19156007756
- Email: qiankeyu1983@163.com
Study Locations
-
-
-
Hefei, China
- Recruiting
- Anhui Provincial Hospital
-
Contact:
- dong qian, M.D.
- Phone Number: +86-19156007756
- Email: qiankeyu1983@163.com
-
Contact:
- Yuan He, M.D.
- Phone Number: +86-18926243766
- Email: heyuan3766@126.com
-
-
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
|
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
|
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
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
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
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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