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A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.

2026年11月4日 更新者：AstraZeneca

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).

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

140

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Beijing、中国、102218
        • 尚未招聘
        • Research Site
      • Beijing、中国、100050
        • 尚未招聘
        • Research Site
      • Beijing、中国、100142
        • 招聘中
        • Research Site
      • Beijing、中国、100730
        • 尚未招聘
        • Research Site
      • Beijing、中国、102206
        • 尚未招聘
        • Research Site
      • Bengbu、中国、233004
        • 尚未招聘
        • Research Site
      • Changchun、中国、130021
        • 尚未招聘
        • Research Site
      • Changchun、中国、130033
        • 招聘中
        • Research Site
      • Changsha、中国、410008
        • 尚未招聘
        • Research Site
      • Changzhi、中国、046000
        • 尚未招聘
        • Research Site
      • Chengdu、中国、610041
        • 招聘中
        • Research Site
      • Chengdu、中国、610041
        • 尚未招聘
        • Research Site
      • Chongqing、中国、400042
        • 尚未招聘
        • Research Site
      • Fuzhou、中国、350001
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510080
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510120
        • 尚未招聘
        • Research Site
      • Guangzhou、中国、510655
        • 尚未招聘
        • Research Site
      • Hangzhou、中国、310014
        • 招聘中
        • Research Site
      • Hangzhou、中国、310016
        • 尚未招聘
        • Research Site
      • Hohhot、中国、010020
        • 尚未招聘
        • Research Site
      • Jinan、中国、250021
        • 尚未招聘
        • Research Site
      • Jinan、中国、250014
        • 招聘中
        • Research Site
      • Kunming、中国、650118
        • 尚未招聘
        • Research Site
      • Lanzhou、中国、730000
        • 招聘中
        • Research Site
      • Lanzhou、中国、730030
        • 尚未招聘
        • Research Site
      • Meizhou、中国、514031
        • 招聘中
        • Research Site
      • Nanchang、中国、330006
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210029
        • 尚未招聘
        • Research Site
      • Nanjing、中国、210009
        • 尚未招聘
        • Research Site
      • Nanning、中国、530021
        • 尚未招聘
        • Research Site
      • Qingdao、中国、266003
        • 招聘中
        • Research Site
      • Shanghai、中国、200032
        • 尚未招聘
        • Research Site
      • Shanghai、中国、201210
        • 尚未招聘
        • Research Site
      • Shanghai、中国、200031
        • 尚未招聘
        • Research Site
      • Shaoguan、中国、512027
        • 招聘中
        • Research Site
      • Shenyang、中国、110042
        • 尚未招聘
        • Research Site
      • Suining Shi、中国、629000
        • 招聘中
        • Research Site
      • Taiyuan、中国、030000
        • 尚未招聘
        • Research Site
      • Wuhan、中国、430030
        • 尚未招聘
        • Research Site
      • Xi'an、中国、710068
        • 招聘中
        • Research Site
      • Zhengzhou、中国、450000
        • 尚未招聘
        • Research Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

    1. Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.

    2. 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.

    3. 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:

    1. Haemoglobin ≥ 9.0 g/dL
    2. Absolute neutrophil count ≥ 1.5 × 109/L
    3. Platelet count ≥ 100 × 109/L
    4. 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.
    5. ALT and AST ≤ 2.5 × ULN
    6. 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.

Exclusion Criteria:

  • -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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm A

Durvalumab +FLOT followed by durvalumab
药品：FLOT Chemotherapy

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

药品：Durvalumab

Human monoclonal antibody
安慰剂比较：Arm B

Placebo +FLOT followed by Placebo
药品：FLOT Chemotherapy

A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
To compare Arm A relative to Arm B on pCR rate
大体时间：Up to 24 months after the last participant is randomized

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

次要结果测量

结果测量
措施说明
大体时间
To compare Arm A relative to Arm B on event-free survival at 24 months (EFS24)
大体时间：Up to 24 months after the last participant is randomized

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
To compare Arm A relative to Arm B on overall survival (OS)
大体时间：Up to 24 months after the last participant is randomized

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
To compare Arm A relative to Arm B on event-free survival (EFS)
大体时间：Up to 24 months after the last participant is randomized

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:

  1. Progression that precludes surgery or requires non-protocol therapy,
  2. Local or distant recurrence or progression of disease, or 3) Death due to any cause.
Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on the rate of complete resection (R0)
大体时间：Up to 24 months after the last participant is randomized

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
To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
大体时间：Up to 24 months after the last participant is randomized

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
To compare Arm A relative to Arm B on disease-free survival (DFS) in participants who undergo R0 resection surgery
大体时间：Up to 24 months after the last participant is randomized

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

其他结果措施

结果测量
措施说明
大体时间
To assess the safety and tolerability of Arm A as compared to Arm B in participants with GC/GEJC
大体时间：Up to 24 months after the last participant is randomized

Safety and tolerability will be evaluated in terms of adverse events (AEs)
Up to 24 months after the last participant is randomized

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年10月9日

初级完成 (估计的)

2029年11月1日

研究完成 (估计的)

2029年11月1日

研究注册日期

首次提交

2026年9月15日

首先提交符合 QC 标准的

2026年10月9日

首次发布 (实际的)

2026年10月16日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • D907JC00001

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

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.

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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