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

RECRUITINGSponsored by Anhui Provincial Hospital
Actively Recruiting
SponsorAnhui Provincial Hospital
Started2023-07-01
Est. completion2026-01-01
Eligibility
Age18 Years – 85 Years
Healthy vol.Accepted

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

Age: 18 Years – 85 YearsHealthy volunteers accepted
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

CancerChemoradiotherapyEsophageal Squamous Cell CarcinomaImmunonutritionInoperable

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