Chemoradiotherapy, Esophageal Squamous Cell Carcinoma, Immunonutrition, Inoperable
Conditions
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.
Interventions
DIETARY_SUPPLEMENTWhole-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.
Sponsors
Anhui Provincial Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse events | 1 month post treatment | Rate of adverse events (CTCAE V4.0) |
| Disease Control Rate | 1 month post treatment | Disease Control Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-, 2-, 3-year Progression-free survival rate (PFS). | 1 to 3 years | 1-, 2-, 3-year Progression-free survival rate (PFS). |
Countries
China
Contacts
Primary Contactdong qian, M.D.
Outcome results
None listed