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Идёт набор NCT07519486

Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC

Фаза II С лечением Esophageal Squamous Cell Carcinoma Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: PD-1 Inhibitor plus Chemotherapy, Oral Enteral Nutritional Preparation, Esophagectomy with lymph node dissection.
Кому может быть актуально
Состояния в реестре: Esophageal Squamous Cell Carcinoma, Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Обзор

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.

Вмешательства

  • Препарат 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.
  • Пищевая добавка Oral Enteral Nutritional Preparation
    Oral enteral nutritional preparation taken twice daily for 2 cycles (each cycle is 3 weeks).
  • Процедура Esophagectomy with lymph node dissection
    Surgical resection of the esophagus and lymph node dissection, planned 4-6 weeks after the completion of conversion therapy.

Первичные конечные точки

  • Pathological Complete Response (pCR) Rate [Срок оценки: At the time of surgery (approximately 4-6 weeks after the completion of conversion therapy).]
Вторичные конечные точки (3)
  • Event-Free Survival (EFS) [Срок оценки: From randomization up to 2 years.]
  • Major Pathological Response (MPR) Rate [Срок оценки: At the time of surgery (approximately 4-6 weeks after conversion therapy).]
  • Objective Response Rate (ORR) [Срок оценки: Approximately 2 months (after completion of 2 cycles of conversion therapy).]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • West China Hospital, Sichuan University — Чэнду

Идентификаторы

NCT: NCT07519486 · 2026-191

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗