Clinical Study of Endostar Injection Concomitant With SOX Protocols to Treat Advanced Gastric Cancer
A Randomized, Open and Control Clinical Study of Endostar Injection Concomitant With SOX Protocols in Treating Advanced Gastric Cancer
Обзор исследования
Статус
Условия
Подробное описание
Multiple pre-clinical studies have indicated that in dozens of animal tumor models and human tumor-metastatic mice tumor models, the effective rate of Endostar was 47%～91% in daily dosage of 10～100mg/kg, and covered human commonly seen malignant tumors, such as lung cancer, gastric cancer, breast cancer, colorectal cancer, hepatic cancer, malignant melanoma and non-Hodgkin's lymphoma, etc.. The development and progression of gastric cancer was in association with angiogenesis. An animal research observed the influence of Endostar on tumor strains in nude mice with gastric cancer, and the results showed that tumor size shrunk rapidly and the expressions of VEGF, bFGF, VEGF-C, VEGFR-3, bcl-2 and PDGF decreased significantly after treatment in experimental group, demonstrating that Endostar could reduce angiogenesis, increase tumor cell apoptosis and inhibit tumor growth in gastric cancer. An investigation of small-sample Endostar concomitant with chemotherapy on patients with advanced gastric cancer primarily indicated the efficacy and feasibility of Endostar concomitant with chemotherapy in treating gastric cancer.
With the expanded application of Endostar in clinic, it also obtains certain effect in treating patients with lung cancer and colorectal cancer. The safety, efficacy, evaluation of relationship between benefit and risk in common or special population as well as the modified dosage of administration of Endostar in wide application should be further explored to provide sufficient scientifical basis for the safety, efficacy, applicable rule in special population and investigation of optimal administrative protocols for Endostar in wide application.
This control, single-center clinical study of EndostarTM Injection with/without SOX protocols to treat advanced gastric cancer was conducted to explore the feasibility, efficacy and safety of Endostar concomitant with SOX protocols, and to provide more evidence-based medical basis for the clinical application of Endostar.
Тип исследования
Регистрация (Ожидаемый)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Xinjiang
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Urumqi, Xinjiang, Китай, 830011
- Cancer Hospital of Xinjiang Medical University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age: 18～70 years;
- Performance status (PS) of Eastern Cooperative Oncology Group (ECOG) was 0～1 or KPS scores were 60-100 scores;
- Patients who were diagnosed with recurrent and metastatic advanced gastric cancer by histopathology and CT;
- Patients who had more than 1 measurable nidus (common CT or MRI scanning ≥20 mm, spiral CT scanning ≥10 mm);
- Patients who had no severe dysfunction of important organs, and were normal in blood routine test, hepatorenal function, electrolytes and cardiac function, with white blood cell count≥4.0×109/L, neutrophil count≥1.5×109/L, platelet count≥100×109/L, hemoglobin≥95g/L, serum bilirubin≤1.5 folds of upper normal limit, Alanine transaminase and glutamic oxalacetic transaminase ≤2 folds of upper normal limit, and serum creatinine≤1.5mg/dl.
- Estimated survival time was above 3 months;
- Patients who were well acknowledged of this study and signed the informed consent forms.
Exclusion Criteria:
- Patients who received whole body treatment of metastatic gastric cancer previously;
- Patients who underwent surgeries within 4 weeks before this study;
- Patients who had allergic constitutions or were allergic to biological products of proteins and to any medicine used in this study;
- Female patients in gestation or lactation period, or those who were interfile but received no contraception measures;
- Patients who were with other symptoms unsuitable to this study;
- Patients who were treated by other anti-tumor methods at that time;
- Patients who had no measurable nidus;
- Patients who had one of the following conditions: uncontrolled metastatic nidus in central nervous system, dysfunction of important organs, severe cardiac diseases (including congestive heart failure, uncontrollable arrhythmia, angina pectoris needed long-term drug treatment, valvular heart diseases and myocardial infarction), hypertension, women in gestation or lactation period, protracted infectious wound as well as uncontrollable psychosis history.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Oxaliplatin & Endostar injection
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14; Endostar injection, 7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10; 21 d as a cycle.
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130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Другие имена:
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Другие имена:
7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
Другие имена:
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Активный компаратор: Oxaliplatin
Oxaliplatin, 130 mg/m2 , iv, 3-4h, d1; Gimeracil and Oteracil Potassium Capsules, 40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
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130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
Другие имена:
40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Response rate (RR)
Временное ограничение: The patients were followed up for 3 years.
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The patients were followed up for 3 years.
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clinical benefit rate (CBR)
Временное ограничение: The patients were followed up for 3 years.
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The patients were followed up for 3 years.
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progression-free survival (PFS)
Временное ограничение: The patients were followed up for 3 years
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PFS was from randomization to tumor progression or death.
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The patients were followed up for 3 years
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Вторичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
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overall survival (OS)
Временное ограничение: The patients were followed up for 3 years
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The patients were followed up for 3 years
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Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Tang Yong, Professor, Cnacer Hospital of Xinjiang Medical University
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания пищеварительной системы
- Новообразования
- Новообразования по локализации
- Желудочно-кишечные новообразования
- Новообразования пищеварительной системы
- Желудочно-кишечные заболевания
- Заболевания желудка
- Новообразования желудка
- Физиологические эффекты лекарств
- Молекулярные механизмы фармакологического действия
- Антиметаболиты, Противоопухолевые
- Антиметаболиты
- Противоопухолевые агенты
- Ингибиторы ангиогенеза
- Агенты, модулирующие ангиогенез
- Вещества роста
- Ингибиторы роста
- Оксалиплатин
- Эндостар белок
- Эндостатины
- Тегафур
Другие идентификационные номера исследования
- XinjiangMU (006)
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Клинические исследования Oxaliplatin
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Hospices Civils de LyonНеизвестный
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Brown UniversityRhode Island HospitalЗавершенныйПанкреатический рак | Местнораспространенный рак поджелудочной железыСоединенные Штаты