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Идёт набор NCT05403242

RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

Фаза I / Фаза II С лечением Advanced Gastroesophageal 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: RC48-ADC, S-1.
Кому может быть актуально
Состояния в реестре: Advanced Gastroesophageal Adenocarcinoma. 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
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

A Multicenter, Open Label，Single Arm，Phase Ib/II Study to Evaluate the Effect and Safety of RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2

Обзор

This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.

Вмешательства

  • Препарат RC48-ADC
    2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks
  • Препарат S-1
    40-60 mg, bid po, d1-10, every 2 weeks

Первичные конечные точки

  • dose-limiting toxity [Срок оценки: through study completion, an average of 1 year]
  • ORR（Objective Response Rate） [Срок оценки: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year]
Вторичные конечные точки (4)
  • PFS(progression-free survival) [Срок оценки: Imaging tests were performed every 8 weeks (±7 days) from the first year of treatment to assess efficacy, and every 7 weeks (±7 days) after 1 year]
  • DOR(Duration of Response ) [Срок оценки: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year]
  • OS(Overall Survival) [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 24 months]
  • AE(Adverse Event) [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

  • At the same time, patients voluntarily participated in the study and signed informed consent;
  • Either male or female, aged 18 or older;
  • Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;
  • No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
  • HER2 IHC 2+ and FISH-;
  • ECOG scores 0-1;
  • Estimated survival ≥3 months;
  • Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
  • Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.

Критерии исключения

  • Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer;
  • Known hypersensitivity to RC48-ADC;
  • HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
  • History of HIV infection;
  • History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment;
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

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 · 3 центра
  • Beijing Friendship Hospital — Пекин
  • Chinese PLA General Hospital — Пекин
  • Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT05403242 · S2022-132-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗