Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PD-1 Inhibitor plus Chemotherapy, Oral Enteral Nutritional Preparation, Esophagectomy with lymph node dissection.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Overview
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.
Interventions
- Drug PD-1 Inhibitor plus Chemotherapy
PD-1 inhibitor combined with chemotherapy (Paclitaxel or Albumin-bound paclitaxel plus Cisplatin or Carboplatin), administered once every 3 weeks for 2 cycles. - Dietary supplement Oral Enteral Nutritional Preparation
Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks). - Procedure Esophagectomy with lymph node dissection
Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.
Primary outcome measures
- Pathological Complete Response (pCR) Rate [Time frame: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).]
Secondary outcome measures (3)
- Event-Free Survival (EFS) [Time frame: From randomization up to 2 years.]
- Major Pathological Response (MPR) Rate [Time frame: At the time of surgery (approximately 4-6 weeks after conversion therapy).]
- Objective Response Rate (ORR) [Time frame: Approximately 2 months (after completion of 2 cycles of conversion therapy).]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital, Sichuan University — Chengdu
Identifiers
NCT: NCT07519486 · 2026-191