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Идёт набор NCT06774222

A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG

Фаза II С лечением Gastric/Gastroesophageal Junction Adenocarcinoma

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.
Кому может быть актуально
Состояния в реестре: Gastric/Gastroesophageal Junction Adenocarcinoma. 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
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Официальное название

A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.

Обзор

Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.

Подробное описание

Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .

Вмешательства

  • Препарат Fruquintinib
    Fruquinitinib: Take 4 mg QD for 2 weeks and stop for 1 week, every 3 weeks for a cycle; Standard chemotherapy: The selection of drugs is recommended by the 2024CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, including SOX, XLOX or S-1, and the treatment cycle is one every 3 weeks

Первичные конечные точки

  • 3-year recurrence-free survival rate [Срок оценки: Three years after surgery]
Вторичные конечные точки (2)
  • Overall survival [Срок оценки: OS is the time interval from the start of treatment to death due to any reason or lost of follow-up，whichever came first, assessed up to 3 years"]
  • AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: from the first drug administration to within 30 days for the last dose]

Критерии участия

Критерии включения

  • Fully understand the study and voluntarily sign the informed consent form;
  • Age between 18 and 75 years;
  • Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;
  • Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;
  • R0 resection after neoadjuvant chemotherapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  • Life expectancy of at least 2 years;
  • No prior anti-cancer treatment received;
  • Good compliance and cooperation with follow-up.

Критерии исключения

  • Inability to comply with the study protocol or procedures;
  • History of prior gastric cancer surgery;
  • Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
  • Distant metastasis to organs other than the liver, such as lung, brain, and bone;
  • Known HER2-positive patients;
  • Uncontrolled hypertension despite medication prior to enrollment;
  • Poorly controlled diabetes despite medication prior to enrollment;
  • Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification >1.0g;
  • Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
  • Patients deemed ineligible for this study by the investigator.

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
  • Henan Cancer Hospital — Чжэнчжоу

Идентификаторы

NCT: NCT06774222 · 2022-421

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗