Actively Recruiting
Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
Led by Sichuan University · Updated on 2026-04-15
118
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC)
- Aged 18 to 80 years, any gender
- ECOG Performance Status 0 to 2
- Less than 10% weight loss within the past 6 months
- Locally advanced unresectable ESCC as defined by NCCN Guidelines (Version 2026.1)
- Planned surgery after conversion therapy with no surgical contraindications
- No prior anti-tumor therapy for ESCC (radiotherapy, chemotherapy, or surgery)
- Presence of measurable lesion(s) per RECIST 1.1
- Expected survival of 3 months or more
- Able to swallow and tolerate oral medications
- Adequate organ function (blood counts, biochemistry, coagulation) per protocol
- Women of childbearing potential and men agree to use effective contraception during study and for 6 months after
- Voluntary participation with signed informed consent and good compliance
You will not qualify if you...
- Presence of esophageal-mediastinal or tracheoesophageal fistula
- Tumor invasion of major vessels with risk of fatal hemorrhage
- History of other cancers within past 5 years
- Use of immunosuppressants or systemic steroids (>10 mg/day prednisone equivalent) within 2 weeks prior to first dose
- Active or history of autoimmune disease requiring systemic treatment
- Known immunodeficiency (e.g., HIV, organ or bone marrow transplant)
- Uncontrolled comorbidities (hypertension, angina, recent myocardial infarction, severe infections)
- Active tuberculosis or untreated history of tuberculosis
- Active Hepatitis B or C infection
- Complete inability to take oral enteral nutrition due to esophageal stenosis
- History or presence of interstitial pneumonia or lung disease
- Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
- Severe gastrointestinal disorders with diarrhea CTCAE grade >2
- Pregnant or lactating women
- Participation in other clinical trials within 30 days before enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
Z
Zhenyu Ding, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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