NCT07519486RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 2 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Sichuan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07519486
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 118
- From 1 Apr 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Uncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).
- Significant gastrointestinal disorders with severe diarrhea (CTCAE \> Grade 2). Pregnant or lactating women. Participation in other clinical trials within 30 days prior to enrollment.
Other illness
- 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.
- 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.
Other
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.