Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC

NCT07519486 | Recruiting Phase 2

• 1 other identifier: 2026-191
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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

Esophageal Squamous Cell Carcinoma; Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Keywords

Esophageal Neoplasms; Nutritional Support; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  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 Outcomes (3)

• Event-Free Survival (EFS)

  From randomization up to 2 years.

• Major Pathological Response (MPR) Rate

  At the time of surgery (approximately 4-6 weeks after conversion therapy).

• Objective Response Rate (ORR)

  Approximately 2 months (after completion of 2 cycles of conversion therapy).

Study Arms (2)

Intensive Nutritional Support Group

EXPERIMENTAL

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; Dietary Supplement: Oral Enteral Nutritional Preparation; Procedure: Esophagectomy with lymph node dissection

Standard Nutritional Support Group

ACTIVE COMPARATOR

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; Procedure: Esophagectomy with lymph node dissection

Interventions

Oral Enteral Nutritional Preparation DIETARY_SUPPLEMENT

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

Intensive Nutritional Support Group

Esophagectomy with lymph node dissection PROCEDURE

Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.

Intensive Nutritional Support Group; Standard Nutritional Support Group

PD-1 Inhibitor plus Chemotherapy DRUG

PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles.

Intensive Nutritional Support Group; Standard Nutritional Support Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms

Interventions

Immune Checkpoint Inhibitors; Drug Therapy; Esophagectomy; Lymph Node Excision

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Zhenyu Ding, PhD

  West China Hospital

  STUDY CHAIR

Central Study Contacts

Zhenyu Ding, PhD

CONTACT

+86-189-8060-1957; dingzhenyu@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available starting 6 months and ending 36 months following article publication.
• 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).

Locations

CN (1)