Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC

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

Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC (NCT07519486) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma and Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, sponsored by Sichuan University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 118 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Esophageal Squamous Cell Carcinoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. your organs (liver, kidneys, etc.) are working well enough based on blood tests (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 willing to sign a consent form and good compliance. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body) or history of autoimmune conditions (where your immune system attacks your own body) requiring systemic treatment. Known weakened immune system 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). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

West China Hospital, Sichuan University

Chengdu, Sichuan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07519486), the sponsor (Sichuan University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07519486 clinical trial studying?

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 impro… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07519486?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07519486?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

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A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma

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Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

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Source: ClinicalTrials.gov API v2 record for NCT07519486. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07519486. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.