NCT07519486 Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
| NCT ID | NCT07519486 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan University |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2026-04 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Zhenyu Ding, PhD
STUDY CHAIR
West China Hospital
Frequently Asked Questions
Who can join the NCT07519486 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07519486 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07519486 currently recruiting?
Yes, NCT07519486 is actively recruiting participants. Contact the research team at dingzhenyu@scu.edu.cn for enrollment information.
Where is the NCT07519486 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07519486 clinical trial?
NCT07519486 is sponsored by Sichuan University. The principal investigator is Zhenyu Ding, PhD at West China Hospital. The trial plans to enroll 118 participants.