Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic 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: H101, Camrelizumab.
- Кому может быть актуально
- Состояния в реестре: Pancreatic Cancer. Базовые параметры: 18 лет — 80 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
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to Patients with Advanced Pancreatic Cancer.
Подробное описание
Pancreatic adenocarcinoma (PDAC) is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. In 2011, the PRODIGE trial has shown that oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) was associated with a survival advantage but had increased toxicity.
Recent studies have suggested that local destruction of tumor tissue by oncolytic virus induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens. PD-1 blocking antibody interferes with PD-1 mediated T-cell regulatory signaling. Combination of PD-1 blocking antibody plus oncolytic virus may increase anti-tumor efficacy in pancreatic cancer.
The purpose of this study is to evaluate the efficacy of oncolytic virus plus PD-1 inhibitor to patients with advanced pancreatic cancer who are refractory to standard chemotherapy. Progression-free survival (PFS), objective response rate (ORR), overall survival (OS) and disease control rate (DCR) are measured every three weeks.
Вмешательства
- Препарат H101
H101 15x10\^11vp intratumorally injection starts at day 1. - Препарат Camrelizumab
Camrelizumab will be administered at 200 mg i.v. every 3 weeks at day 2.
Первичные конечные точки
- Overall survival，OS [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
Вторичные конечные точки (3)
- progression-free survival, PFS [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
- objective response rate (ORR) [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
- disease control rate (DCR) [Срок оценки: At the end of Cycle 1 (each cycle is 21 days)]
Критерии участия
Критерии включения
- Ability to understand and the willingness to sign a written informed consent document.
- Age ≥ 18 years and ≤ 80 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Histologically or cytologically confirmed advanced pancreas adenocarcinoma.
- Patients who have received at least two lines of anti-tumor chemotherapy, or patients who have been unsuitable or unwilling to standard therapy.
- Locally advanced, or metastatic pancreatic cancer.
- Presence of at least of one measurable lesion in agreement to RECIST criteria.
- The expected survival ≥ 3 months.
- Adequate organ performance based on laboratory blood tests.
- Patients who are willing or able to comply with study procedures.
Критерии исключения
- Pregnant or nursing women.
- Primary pancreatic cancer, or prior treatment with oncolytic virus and PD-1 inhibitor.
- The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
- Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
- Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- Allergic to study drugs.
- Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
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
Список центров уточняется — проверьте первичный протокол.
Публикации
- Chiu M, Armstrong EJL, Jennings V, Foo S, Crespo-Rodriguez E, Bozhanova G, Patin EC, McLaughlin M, Mansfield D, Baker G, Grove L, Pedersen M, Kyula J, Roulstone V, Wilkins A, McDonald F, Harrington K, Melcher A. Combination therapy with oncolytic viruses and immune checkpoint inhibitors. Expert Opin Biol Ther. 2020 Jun;20(6):635-652. doi: 10.1080/14712598.2020.1729351. Epub 2020 Feb 23. PMID 32067509
- Zhang Y, Qian L, Chen K, Gu S, Wang J, Meng Z, Li Y, Wang P. Intraperitoneal oncolytic virotherapy for patients with malignant ascites: Characterization of clinical efficacy and antitumor immune response. Mol Ther Oncolytics. 2022 Mar 15;25:31-42. doi: 10.1016/j.omto.2022.03.003. eCollection 2022 Jun 16. PMID 35399603
Идентификаторы
NCT: NCT06196671 · PTCA199-8