Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal Neoplasms, Nutritional Support, Neoadjuvant Therapy
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.
Interventions
DRUGPD-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_SUPPLEMENTOral Enteral Nutritional Preparation
Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).
PROCEDUREEsophagectomy with lymph node dissection
Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.
Sponsors
Sichuan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) Rate | At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy). | Defined as the absence of residual viable tumor cells in the primary tumor bed and all sampled lymph nodes (ypT0N0) according to the Mandard regression criteria, as evaluated by a blinded Independent Review Committee (BIRC). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-Free Survival (EFS) | From randomization up to 2 years. | The time from randomization to the date of first documentation of disease progression, recurrence after surgery, or death from any cause. |
| Major Pathological Response (MPR) Rate | At the time of surgery (approximately 4-6 weeks after conversion therapy). | Defined as ≤ 10% residual viable tumor cells in the primary tumor bed |
| Objective Response Rate (ORR) | Approximately 2 months (after completion of 2 cycles of conversion therapy). | The percentage of participants with a complete response (CR) or partial response (PR) as per RECIST v1.1 before surgery. |
Countries
China
Contacts
CONTACTZhenyu Ding, PhD
STUDY_CHAIRZhenyu Ding, PhD
West China Hospital
Outcome results
None listed