Whole-course Immunonutrition Combined With Chemoradiotherapy±ICIs for Local Advanced Patients With Inoperable Esophageal Squamous Cell Carcinoma
NCT05833594
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 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.
Conditions5
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NCT05833594