Back to resultsWhole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Immunonutrition
Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Anhui provincial hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Comparator
Arm Description
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Whole-course nutrition Combined With Chemoradiotherapy±ICIs
Outcomes
Primary Outcome Measures
Rate of adverse events
Rate of adverse events (CTCAE V4.0)
Disease Control Rate
Disease Control Rate
Secondary Outcome Measures
1-, 2-, 3-year Progression-free survival rate (PFS).
1-, 2-, 3-year Progression-free survival rate (PFS).
Full Information
NCT ID
NCT05833594
First Posted
April 16, 2023
Last Updated
April 16, 2023
Sponsor
Anhui Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05833594
Brief Title
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
Official Title
Anhui Provincial Hospita
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Provincial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Immunonutrition, Inoperable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
Whole-course nutrition Combined With Chemoradiotherapy±ICIs
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Intervention Description
The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.
Primary Outcome Measure Information:
Title
Rate of adverse events
Description
Rate of adverse events (CTCAE V4.0)
Time Frame
1 month post treatment
Title
Disease Control Rate
Description
Disease Control Rate
Time Frame
1 month post treatment
Secondary Outcome Measure Information:
Title
1-, 2-, 3-year Progression-free survival rate (PFS).
Description
1-, 2-, 3-year Progression-free survival rate (PFS).
Time Frame
1 to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dong qian, M.D.
Phone
+86-19156007756
Email
qiankeyu1983@163.com
Facility Information:
Facility Name
Anhui provincial hospital
City
Hefei
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dong qian, M.D.
Phone
+86-19156007756
Email
qiankeyu1983@163.com
First Name & Middle Initial & Last Name & Degree
Yuan He, M.D.
Phone
+86-18926243766
Email
heyuan3766@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
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