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NOT YET RECRUITING
NCT07519486
PHASE2

Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC

Sponsor: Sichuan University

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DIETARY_SUPPLEMENT

Oral Enteral Nutritional Preparation

Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).

PROCEDURE

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