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Набор скоро начнётся NCT06871527

Fruquintinib Combined With PD-1 Inhibitor and FOLFOX as First-Line Treatment For Advanced Gastric Cancer

Фаза I / Фаза II С лечением Gastric (Stomach) Cancer Gastric Adenocarcinoma Fruquintinib PD-1 Inhibitor

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: fruquintinib + tislelizumab + FOLFOX.
Кому может быть актуально
Состояния в реестре: Gastric (Stomach) Cancer, Gastric Adenocarcinoma, Fruquintinib, PD-1 Inhibitor. 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

Fruquintinib Combined With Tislelizumab and FOLFOX as First-Line Treatment For Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-center, Open-label, Phase Ib/II Clinical Study

Обзор

This study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and FOLFOX regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Вмешательства

  • Препарат fruquintinib + tislelizumab + FOLFOX
    phase Ib: fruquintinib (3+3 dose escalation design): L1: 3 mg/d, L2: 4 mg/d, L3: 5 mg/d, qd po, D1-14, Q3W; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin : 400mg/m2, I.V., D1, Q2W; Oxaliplatin: 85mg/m2, ivgtt 2h, D1, Q2W. phase II: fruquintinib: RP2D; tislelizumab: 200mg, I.V., D1, Q2W; 5-Fluorouracil: 400mg/m2, D1, followed by 2400 mg/m2 as a continuous IV infusion over 46 hours,Q2W; leucovorin

Первичные конечные точки

  • Phase Ib: Maximum tolerated dose (MTD) [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
  • Phase Ib: RD [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
  • Six-month progression-free survival [Срок оценки: At six months]
Вторичные конечные точки (4)
  • PFS [Срок оценки: Up to 3 years]
  • OS [Срок оценки: Up to 3 years]
  • ORR [Срок оценки: Up to 3 years]
  • DCR [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • 18-75 years old (including 18 and 75 years old);
  • Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
  • Pathologically determined gastric or gastroesophageal junction adenocarcinoma;
  • Advanced patients with radiographic confirmation of inoperable complete resection;
  • No previous anti-tumor treatment for metastatic diseases;
  • At least one measurable lesion according to RECIST version 1.1;
  • Ability to take medications orally;
  • No active bleeding;
  • Adequate organ functions:

Absolute neutrophil count ≥2×109/L; Platelet ≥100×109/L; Hemoglobin ≥90g/L; WBC≥4×109/L Total bilirubin ≤ 1.5XULN; ALT and AST ≤2.5XULN ； Serum creatinine (Cr) ≤1.5XULN；

  • Have fully understood the study and voluntarily signed the informed consent;

Критерии исключения

  • Patients who had received any drug in the study protocol in the last year;
  • Deficient mismatch repair (dMMR) or MSI-H detected by genetic test;
  • HER2 positive（HER-2 3+, or HER-2 2+ and FISH+）;
  • Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg;
  • Patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment;
  • Patients with massive pleural or peritoneal effusion requiring drainage;
  • Patients with severe ECG abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment;
  • Severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
  • Mental disorders or central nervous system diseases or brain metastases affecting clinical treatment;
  • Patients with autoimmune diseases;
  • Patients with grade 3 or higher bleeding within 4 weeks;
  • Patients with a history of allergy to any drug, similar drug or vehicle in this study;
  • Had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy;
  • Patients with nonhealed wounds, ulcers, or fractures;
  • Patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment;
  • Pregnant or lactating women, or patients of childbearing age who refused contraception during the study period;
  • Investigators believe that the patient has any other conditions that are not suitable for participating in the study.

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
  • The Sixth Affiliated Hospital of Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06871527 · 2025ZSLYEC-081

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗