A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
A Randomized, Double-blind, Placebo-controlled Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC) (MATTERHORN-CN).
This study aims to assess the efficacy and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to placebo in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Informed by the favorable benefit-risk profile demonstrated by the global MATTERHORN study, the current study is designed to assess the efficacy and safety of neoadjuvant-adjuvant durvalumab in combination with FLOT chemotherapy followed by adjuvant durvalumab monotherapy (Arm A), compared with neoadjuvant-adjuvant placebo in combination with FLOT chemotherapy followed by adjuvant placebo monotherapy (Arm B) in Chinese participants with resectable GC/GEJC. Approximately 140 participants will be randomized to either Arm A or Arm B.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 3
Контакты и местонахождение
Контакты исследования
- Имя: AstraZeneca Clinical Study Information Center
- Номер телефона: 1-877-240-9479
- Электронная почта: information.center@astrazeneca.com
Места учебы
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Beijing, Китай, 102218
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Beijing, Китай, 100050
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Beijing, Китай, 100142
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Beijing, Китай, 100730
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Beijing, Китай, 102206
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Bengbu, Китай, 233004
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Changchun, Китай, 130021
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Changchun, Китай, 130033
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Changsha, Китай, 410008
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Changzhi, Китай, 046000
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Chengdu, Китай, 610041
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Chengdu, Китай, 610041
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Chongqing, Китай, 400042
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Fuzhou, Китай, 350001
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Guangzhou, Китай, 510080
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Guangzhou, Китай, 510120
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Guangzhou, Китай, 510655
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Hangzhou, Китай, 310014
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Hangzhou, Китай, 310016
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Hohhot, Китай, 010020
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Jinan, Китай, 250021
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Jinan, Китай, 250014
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Kunming, Китай, 650118
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Lanzhou, Китай, 730000
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Lanzhou, Китай, 730030
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Meizhou, Китай, 514031
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Nanchang, Китай, 330006
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Nanjing, Китай, 210029
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Nanjing, Китай, 210009
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Nanning, Китай, 530021
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Qingdao, Китай, 266003
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Shanghai, Китай, 200032
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Shanghai, Китай, 201210
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Shanghai, Китай, 200031
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Shaoguan, Китай, 512027
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Shenyang, Китай, 110042
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Suining Shi, Китай, 629000
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Taiyuan, Китай, 030000
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Wuhan, Китай, 430030
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Xi'an, Китай, 710068
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Zhengzhou, Китай, 450000
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
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1. Capable of giving signed informed consent. 2. Male and/or Female, Age ≥ 18 years at the time of screening. 3. Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease, GEJC includes Siewert* type 2 and 3 tumour and Siewert* type 1 tumour.
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Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.
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At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon.
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No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.
4. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
5. Adequate organ and marrow function as defined below:
- Haemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1.5 × 109/L
- Platelet count ≥ 100 × 109/L
- Serum bilirubin ≤ 1.5 ×ULN. This will not apply to participants with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
- ALT and AST ≤ 2.5 × ULN
- Measured CL > 50 mL/min or Calculated CL > 50 mL/min as determined by Cockcroft-Gault (using actual body weight) 6. Must have a life expectancy of at least 24 weeks. 7. Body weight > 30 kg at enrolment and randomization. 8. Meeting tumour sample requirements (at screening) to confirm PD-L1 status.
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Exclusion Criteria:
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-1. Participants with peritoneal dissemination (including tumour cells in peritoneal fluid) or distant metastasis.
2. Participants with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumour.
3. History of allogeneic organ transplantation. 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis.
5. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
6. History of another primary malignancy except for
(a) Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated carcinoma in situ without evidence of disease 7. History of active primary immunodeficiency. 8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) and HIV verified by positive HIV-1 or HIV-2 antibodies.
9. Mean QTc ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
10. Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Arm A
Durvalumab +FLOT followed by durvalumab |
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel Human monoclonal antibody |
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Плацебо Компаратор: Arm B
Placebo +FLOT followed by Placebo |
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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To compare Arm A relative to Arm B on pCR rate
Временное ограничение: Up to 24 months after the last participant is randomized
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pCR rate is defined as the proportion of participants who have no residual viable tumour in the resected specimens and as determined by central pathology review. |
Up to 24 months after the last participant is randomized
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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To compare Arm A relative to Arm B on event-free survival at 24 months (EFS24)
Временное ограничение: Up to 24 months after the last participant is randomized
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EFS24 is the proportion of participants alive and event free 24 months after randomization, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 per Investigator assessment and/or locally by pathology testing. |
Up to 24 months after the last participant is randomized
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To compare Arm A relative to Arm B on overall survival (OS)
Временное ограничение: Up to 24 months after the last participant is randomized
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Overall survival is length of time from randomization until the date of death due to any cause. |
Up to 24 months after the last participant is randomized
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To compare Arm A relative to Arm B on event-free survival (EFS)
Временное ограничение: Up to 24 months after the last participant is randomized
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EFS is defined as the time from randomization to the following, according to RECIST 1.1 per Investigator assessment and/or locally by pathology testing:
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Up to 24 months after the last participant is randomized
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To compare Arm A relative to Arm B on the rate of complete resection (R0)
Временное ограничение: Up to 24 months after the last participant is randomized
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R0 resection (complete resection) rate is the proportion of participants who have a confirmed complete resection as assessed by pathology review. |
Up to 24 months after the last participant is randomized
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To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
Временное ограничение: Up to 24 months after the last participant is randomized
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MFS is the time from randomization until the development of metastasis using RECIST 1.1 or death due to any cause. • DSS is the time from randomization untildeath due to GC/GEJC. |
Up to 24 months after the last participant is randomized
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To compare Arm A relative to Arm B on disease-free survival (DFS) in participants who undergo R0 resection surgery
Временное ограничение: Up to 24 months after the last participant is randomized
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DFS is defined as the time from first post-surgery scan until disease recurrence, using RECIST 1.1, or death due to any cause. |
Up to 24 months after the last participant is randomized
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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To assess the safety and tolerability of Arm A as compared to Arm B in participants with GC/GEJC
Временное ограничение: Up to 24 months after the last participant is randomized
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Safety and tolerability will be evaluated in terms of adverse events (AEs) |
Up to 24 months after the last participant is randomized
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- D907JC00001
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
IPD will be sharedQualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. upon certain conditions.
Сроки обмена IPD
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Критерии совместного доступа к IPD
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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