Intensive nutrition during conversion therapy to enable surgery for locally advanced unresectable esophageal squamous cell carcinoma
A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
PHASE2 · Sichuan University · NCT07519486
This will test whether giving intensive enteral nutrition alongside PD-1 inhibitor plus chemotherapy helps people with locally advanced unresectable esophageal squamous cell carcinoma achieve higher rates of complete tumor removal after conversion therapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sichuan University (other) |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT07519486 on ClinicalTrials.gov |
What this trial studies
This Phase 2 randomized study enrolls patients with locally advanced unresectable esophageal squamous cell carcinoma who are receiving PD-1 inhibitor combined with chemotherapy. Participants are randomly assigned to intensive enteral nutritional support or standard nutritional care during conversion therapy. After systemic therapy, patients planned for surgery undergo esophagectomy with lymph node dissection and the primary endpoint is pathological complete response (pCR) at surgery. Safety, treatment tolerance, and other clinical outcomes will also be tracked.
Who should consider this trial
Good fit: Ideal candidates are adults (18–80) with pathologically confirmed locally advanced unresectable ESCC, ECOG 0–2, treatment‑naive, able to take oral enteral nutrition, planned for surgery after conversion therapy, and with adequate organ function.
Not a fit: Patients with prior anti‑tumor therapy for ESCC, distant metastatic disease, inability to tolerate oral nutrition or surgery, or significant organ dysfunction are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, intensive nutritional support could increase pCR rates, improve tolerance to chemo‑immunotherapy, and make more patients eligible for curative surgery.
How similar studies have performed: Nutritional support has improved treatment tolerance and outcomes in other upper gastrointestinal cancers, but combining intensive enteral nutrition with PD-1 inhibitor plus chemotherapy specifically to boost pCR in conversion therapy for ESCC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chengdu, Sichuan
- West China Hospital, Sichuan University — Chengdu, Sichuan, China (RECRUITING)
Study contacts
- Study coordinator: Zhenyu Ding, PhD
- Email: dingzhenyu@scu.edu.cn
- Phone: +86-189-8060-1957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Nutritional Support, Neoadjuvant Therapy