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Trial Title:
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05833594
Condition:
Esophageal Squamous Cell Carcinoma
Chemoradiotherapy
Immunonutrition
Inoperable
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Description:
The Experimental group received a combination of omega-3 fatty acids, and glutamine,
whereas the control group received standard formula.
Arm group label:
Comparator
Arm group label:
Experimental
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.
Criteria for eligibility:
Study pop:
- 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.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui provincial hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Contact:
Last name:
dong qian, M.D.
Phone:
+86-19156007756
Email:
qiankeyu1983@163.com
Contact backup:
Last name:
Yuan He, M.D.
Phone:
+86-18926243766
Email:
heyuan3766@126.com
Start date:
July 1, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Source:
Anhui Provincial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05833594
