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Can a Pre-Surgery diet cut complications in esophageal cancer?

NCT ID NCT04513418

Disease control Sponsor: Hecheng Li M.D., Ph.D Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special immune-boosting diet given before surgery can lower the risk of complications like infections and digestive issues in people with esophageal cancer. About 244 participants who have had chemotherapy and radiation will receive either the special diet or standard nutrition. The goal is to see if this approach improves recovery after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 244 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2020

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed esophageal cancer * Staging as cT2N0M0 with high-risk lesions (lymphovascular invasion, ≥3cm, poorly differentiated) / cT1b-2N+M0 / cT3-4aN0-3M0 with the need of neoadjuvant therapy before radical esophagectomy * Tolerance with oral intake (at least fluid diet) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Body Mass Index (BMI) ≥ 18.5 kg/m2 before recruitment * Patient's approval and written informed consent Exclusion Criteria: * Expected survival time less than 6 months * Complete dysphagia * Pregnant or breast-feeding women * Unable to obey the interventions because of any reasons * Serious co-morbidities (cardiac, pulmonary, liver, kidney, brain, hematologic, endocrine and other diseases) in patients who cannot tolerate neoadjuvant therapy and/or surgery * History of previous thoracic or abdominal surgery * History of other malignant tumor (previous or current) * Patients with primary small cell carcinoma of the esophagus

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms neoplasm of esophagus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal neoplasms

Contacts and locations

Locations

  • Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315048, China

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025, China

  • Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200011, China

  • Zhongshan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032, China

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