Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
Anhui Provincial Hospita
Anhui Provincial Hospital
70 participants
Jul 1, 2023
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria8
- 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.
Interventions
The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05833594