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Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC

NCT07519486 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-04-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Sichuan University

    lead OTHER

Principal Investigators

  • Zhenyu Ding, PhD · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-09-30
Completion
2028-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07519486 on ClinicalTrials.gov