Идёт набор NCT06532006

A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

Фаза III С лечением Gastroesophageal-junction Cancer Monoclonal Antibody Gastric Cancer HER2-positive Gastric Cancer

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: HLX22, Pembrolizumab, Trastuzumab, Oxaliplatin.
Кому может быть актуально: Состояния в реестре: Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer. Базовые параметры: от 18 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: США, Аргентина, Австралия, Бразилия, Чили +12
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

A Randomized, Double-blinded, Multicenter, Phase Ⅲ Clinical Study of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination With Trastuzumab and Chemotherapy (XELOX) Versus Trastuzumab and Chemotherapy (XELOX) With or Without Pembrolizumab for the First Line Treatment of Locally Advanced or Metastatic Gastroesophageal Junction and Gastric Cancer

Обзор

This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).

Подробное описание

In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo (for pembrolizumab), once every 3 weeks (Q3W).

In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ± pembrolizumab, Q3W.

Вмешательства

Препарат HLX22
HLX22 15mg/kg Q3w
Препарат Pembrolizumab
Pembrolizumab 200mg q3w
Препарат Trastuzumab
Trastuzumab 8 mg/kg loading dose and then 6 mg/kg maintenance thereafter ,Q3W
Препарат Oxaliplatin
Oxaliplatin 130 mg/m2 ,Q3W
Препарат Capecitabine
Capecitabine 1000 mg/m2 bid on Days 1-14 ,Q3W

Первичные конечные точки

Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) [Срок оценки: Up to 5 years]
Overall Survival （OS） [Срок оценки: Up to 5 years]

Вторичные конечные точки (3)

PFS per RECIST 1.1 assessed by investigator [Срок оценки: Up to 5 years]
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1 [Срок оценки: Up to 5 years]
Adverse events (AE) [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

Male/female who are at least 18 years of age on the day of signing the informed consent.
With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.
HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.
ECOG PS within 7 days before randomization: 0-1.
Expected survival ≥ 6 months.
Had adequate organ function

Критерии исключения

Patients with other malignant tumors within 2 years before the randomization.
Evidence of disease progression within 6 months (before randomization) after completion of prior neoadjuvant or adjuvant chemotherapy (or both) or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
Previous treatment with any HER2-target therapy.
Active gastrointestinal bleeding
Presence of central nervous system (CNS) metastases.
Left ventricular ejection fraction (LVEF) < 55%.
Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.

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: Четверное слепое
Основная цель: Лечение

Центры проведения

Китай · 48 центров

Affiliated Hospital of Youjiang Medical University for Nationalities — Baise City
Beijing Cancer Hospital — Пекин
Cancer Hospital Chinese Academy of Medical Sciences — Пекин
Peking Union Medical College Hospital — Пекин
The First Affiliated Hospital of Bengbu Medical University — Bengbu
The First Hospital of Jilin University — Changchun
Hunan Cancer Hospital — Чанша
Heping Hospital Affiliated to Changzhi Medical College — Changzhi
… и ещё 40 центров

США · 29 центров

Los Angeles Cancer Network — Anaheim
OPN - Oncology Physician Network (Los Alamitos) — Los Alamitos
Banner MD Anderson Cancer Center — Greeley
Advanced Research LLC — Deerfield Beach
Florida Cancer Specialist - South — Fort Myers
BRCR Medical Center — Plantation
Napa Research — Pompano Beach
Florida Cancer Specialist - North — St. Petersburg
… и ещё 21 центр

Япония · 26 центров