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

Launched by ANHUI PROVINCIAL HOSPITAL · Apr 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with inoperable esophageal squamous cell carcinoma, which is a type of cancer in the esophagus. The researchers want to see if adding a special nutritional support called immunonutrition—made from ingredients like omega-3 fatty acids and glutamine—to standard cancer treatments like chemoradiotherapy (a combination of chemotherapy and radiation) can improve patient outcomes. They will compare this new approach to standard nutrition during treatment to find out if it helps patients live longer without their cancer worsening.

To be eligible for this study, participants must be between 18 and 85 years old and have a confirmed diagnosis of esophageal squamous cell carcinoma that cannot be surgically removed. They should not have received any previous cancer treatments and must be in good enough health to tolerate the study treatments. If someone joins the trial, they can expect to receive either the new immunonutrition combined with chemoradiotherapy or the standard nutrition with the same cancer treatment. The goal is to find out which method is more effective and safer, ultimately helping doctors provide better care for patients facing this challenging diagnosis.

Gender

ALL

Eligibility criteria

• 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.