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Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
Sponsor: Sichuan University
Summary
Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC) undergoing conversion therapy. Participants receiving PD-1 inhibitors combined with chemotherapy will be randomly assigned to either intensive nutritional support or standard care. The primary goal is to determine if intensive nutritional support can improve the pathological complete response (pCR) rate after subsequent surgery.
Official title: A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2026-04
Completion Date
2028-03
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
PD-1 Inhibitor plus Chemotherapy
PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles.
Oral Enteral Nutritional Preparation
Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).
Esophagectomy with lymph node dissection
Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.
Locations (1)
West China Hospital, Sichuan University
Chengdu, Sichuan, China