Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC (INS-ESCC-CT)

April 10, 2026 updated by: Zhen-Yu Ding, Sichuan University

A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

118

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Pathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC). Aged 18-80 years, regardless of gender. ECOG Performance Status (PS) 0-2, and weight loss < 10% within the past 6 months.

Confirmed locally advanced unresectable ESCC according to NCCN Guidelines (Version 2026.1).

Planned to receive surgery after completion of conversion therapy, with no surgical contraindications.

Treatment-naive: No prior anti-tumor therapy for ESCC, including radiotherapy, chemotherapy, or surgery.

Presence of measurable lesion(s) according to RECIST 1.1. Expected survival ≥ 3 months. Able to swallow and tolerate oral medications. Adequate organ function (blood counts, biochemistry, and coagulation parameters meeting protocol requirements).

Women of childbearing age and men must agree to use effective contraception during the study and for 6 months after completion.

Voluntary participation with signed informed consent and good compliance.

Exclusion Criteria:

Presence of esophageal-mediastinal fistula and/or tracheoesophageal fistula, or tumor invasion of major vessels with risk of fatal hemorrhage.

History of other malignant tumors within the past 5 years. Current or prior use of immunosuppressants or systemic steroids (>10 mg/day prednisone equivalent) within 2 weeks prior to first dose.

Active autoimmune disease or history of autoimmune disease requiring systemic treatment.

Known immunodeficiency history, including HIV infection, organ transplant, or bone marrow transplant.

Uncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).

Active tuberculosis (TB) or history of TB without standardized treatment. Active Hepatitis B (HBV) or Hepatitis C (HCV) infection. Complete inability to take oral enteral nutrition due to esophageal stenosis. History or current presence of interstitial pneumonia or interstitial lung disease.

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.

Significant gastrointestinal disorders with severe diarrhea (CTCAE > Grade 2). Pregnant or lactating women. Participation in other clinical trials within 30 days prior to enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive Nutritional Support Group
Patients in this group receive intensive oral enteral nutritional support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy).
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.
Active Comparator: Standard Nutritional Support Group
Patients in this group receive routine nutritional guidance/support in addition to the standard conversion therapy (PD-1 inhibitor plus chemotherapy)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological Complete Response (pCR) Rate
Time Frame: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).
Defined as the absence of residual viable tumor cells in the primary tumor bed and all sampled lymph nodes (ypT0N0) according to the Mandard regression criteria, as evaluated by a blinded Independent Review Committee (BIRC).
At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: From randomization up to 2 years.
The time from randomization to the date of first documentation of disease progression, recurrence after surgery, or death from any cause.
From randomization up to 2 years.
Major Pathological Response (MPR) Rate
Time Frame: At the time of surgery (approximately 4-6 weeks after conversion therapy).
Defined as ≤ 10% residual viable tumor cells in the primary tumor bed
At the time of surgery (approximately 4-6 weeks after conversion therapy).
Objective Response Rate (ORR)
Time Frame: Approximately 2 months (after completion of 2 cycles of conversion therapy).
The percentage of participants with a complete response (CR) or partial response (PR) as per RECIST v1.1 before surgery.
Approximately 2 months (after completion of 2 cycles of conversion therapy).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan University

Investigators

  • Study Chair: Zhenyu Ding, PhD, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 2, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data (IPD) that underlie the results reported in the primary publication, after de-identification (text, tables, figures, and appendices), will be shared with researchers to support the results.

IPD Sharing Time Frame

Data will be available starting 6 months and ending 36 months following article publication.

IPD Sharing Access Criteria

Data will be available to researchers who provide a methodologically sound proposal to achieve the objectives in the approved proposal. Proposals should be directed to the corresponding author (Zhenyu Ding).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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