Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Anhui Provincial Hospita

Conditions
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Esophageal Squamous Cell Carcinoma, Chemoradiotherapy, Immunonutrition, Inoperable

Intervention / Treatment
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* Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs | Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs<br>* The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.<br>|
| Comparator<br>Whole-course nutrition Combined With Chemoradiotherapy±ICIs | Dietary Supplement: Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs<br>* The Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events | Rate of adverse events (CTCAE V4.0) | 1 month post treatment | 
| Disease Control Rate | 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). | 1-, 2-, 3-year Progression-free survival rate (PFS). | 1 to 3 years |