About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
18-85 years old;
Eastern Cooperative Oncology Group (ECOG) 0-2;
Esophageal squamous cell carcinoma;
cT2-4aN0-3M0 (AJCC 8th) confirmed by radiological examination;
Disqualifiers
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;
Trial population
* 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.
Trial design
Case-control
Prospective
Treatments tested in this trial
Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs
Dietary supplementThe Experimental group received a combination of omega-3 fatty acids, and glutamine, whereas the control group received standard formula.
Treatment groups
Trial outcomes
Primary outcomes
Rate of adverse events
Rate of adverse events (CTCAE V4.0)
Disease Control Rate
Disease Control Rate
Secondary outcomes
1-, 2-, 3-year Progression-free survival rate (PFS).
1-, 2-, 3-year Progression-free survival rate (PFS).
Sponsors and contacts
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