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Идёт набор NCT06371586

Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC

Фаза II С лечением Gastric Cancer Diffuse Type 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: Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy.
Кому может быть актуально
Состояния в реестре: Gastric Cancer, Diffuse Type Carcinoma. Базовые параметры: 18 лет — 75 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Neo-Sequence 2：Phase 2 Study of Neoadjuvant Chemotherapy Plus Anti-angiogenesis Therapy and Immunotherapy for Locally Advanced Diffuse Gastric Cancer

Обзор

The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.

Подробное описание

The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the dual cycle regimen ofAlbumin paclitaxel+Bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.

Вмешательства

  • Препарат Albumin paclitaxel+SOX+BEV+ PD-1 monoclonal antibody therapy
    Albumin paclitaxel+SOX+BEV bi weekly neoadjuvant therapy for 6 cycles, with PD-1 monoclonal antibody therapy interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the two-week regimen of albumin paclitaxel+bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery

Первичные конечные точки

  • Pathological response rate [Срок оценки: 3 year]
Вторичные конечные точки (4)
  • EFS [Срок оценки: 3 year]
  • OS [Срок оценки: 3 year]
  • R0 [Срок оценки: 3 year]
  • Safety (adverse events) and surgical complications [Срок оценки: 3 year]

Критерии участия

Критерии включения

  • Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
  • Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition);
  • Has not received any anti-tumor treatment for gastric cancer yet;
  • Age range from 18 to 75 years old;
  • ECOG score 0-1 points;
  • Liver and kidney function and blood routine meet the following conditions:

Neutrophils>1.5G/L, Hb>90g/L, PLT>100G/L; ALT and AST<2.5ULN; TBIL<1.5 ULN; Cr<1.0ULN;

  • Left ventricular ejection fraction>60%;
  • Good compliance and ability to accept long-term follow-up;
  • Sign informed consent.

Критерии исключения

  • Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
  • Those who cannot swallow pills;
  • Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
  • Interstitial pneumonia;
  • Moderate to severe cirrhosis caused by any reason;
  • Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
  • Active infections that require systemic treatment;
  • Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
  • Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
  • Pregnant and lactating patients;
  • Individuals with a history of mental illness and poor compliance.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Cancer hospital，Chinese acadamy of medical sciences — Пекин

Идентификаторы

NCT: NCT06371586 · NCC4537

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗