Personalized Neoantigen Vaccine Plus IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC (IMPACT31)
2026年9月3日 更新者：Geneos Therapeutics
IMPACT31: A Randomized Open-label, Multi-center, Phase II Adjuvant Study of a Personalized Neoantigen DNA Vaccine (GNOS-PV02) and Plasmid Encoded IL-12 (INO-9012) Versus Active Surveillance in Subjects With High-Risk HCC
This is a randomized, open-label, multi-site Phase II study of a personalized neoantigen DNA vaccine (GNOS-PV02) and plasmid encoded IL-12 (INO-9012) in subjects with histologically or cytologically confirmed diagnosis of HCC based on pathology report, who were eligible to undergo definitive resection, have demonstrated laboratory, radiographic and/or pathologic high-risk criteria for recurrence (described under eligibility), have no evidence of disease (NED) as per MRI approximately 28 days post resection, and are able to provide a tissue sample for personalized neoantigen DNA vaccine development.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
90
阶段
- 阶段2
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
- 姓名：Joann Peters, MHA
- 电话号码：434-825-2551
- 邮箱：peters@geneostx.com
学习地点
-
-
-
Auckland、新西兰、1023
- 招聘中
- Auckland City Hospital (Te Toka Tumai)
-
接触：
- Principal Investigator, MD
- 电话号码：22932 64 0800 488 434
- 邮箱：LiverResearchUnit@adhb.govt.nz
-
-
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- 尚未招聘
- Emory University
-
接触：
- Principal Investigator, MD
- 电话号码：404-251-1278
- 邮箱：kathleen.marie.coleman@emory.edu
-
-
Louisiana
-
New Orleans、Louisiana、美国、70112
- 招聘中
- Louisiana State University Health Sciences Center
-
接触：
- Principal Investigator, MD
- 电话号码：504-568-4750
- 邮箱：omoave@lsuhsc.edu
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- 招聘中
- Johns Hopkins University
-
接触：
- Principal Investigator, MD
- 电话号码：410-955-8893
- 邮箱：GIClinicalTrials@jh.edu
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- 尚未招聘
- University of Michigan
-
接触：
- Principal Investigator, MD
- 电话号码：734-936-8643
- 邮箱：ndparikh@med.umich.edu
-
-
New York
-
New York、New York、美国、10029
- 招聘中
- Icahn School of Medicine at Mount Sinai
-
接触：
- Principal Investigator, MD
- 电话号码：212-241-7840
- 邮箱：denise.rodriguez3@mssm.edu
-
-
Texas
-
Houston、Texas、美国、77030
- 尚未招聘
- MD Anderson Cancer Center
-
接触：
- Principal Investigator, MD
- 电话号码：713-792-2828
- 邮箱：GIClinicalTrials@mdanderson.org
-
-
Washington
-
Seattle、Washington、美国、98109
- 尚未招聘
- Fred Hutchinson Cancer Center
-
接触：
- Principal Investigator, MD
- 电话号码：206-667-1392
- 邮箱：giresearch@fredhutch.org
-
-
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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Written informed consent
- ≥18 years of age
- Histologically or cytologically confirmed diagnosis of HCC (not accepted: fibrolamellar, sarcomatoid, mixed cholangiocarcinoma)
- Child-Pugh Class A liver score
- Documented virology status of hepatitis
- Availability of a representative post-resection tumor tissue sample
- ECOG performance status of 0 or 1
- Adequate organ function
- Women of childbearing potential (WOCBP) and men must be willing to use an adequate method of contraception
Exclusion Criteria:
- Is currently participating in and receiving study drug or has participated in a study of an investigational agent and received study drug or used an investigation device, within 4 weeks to baseline
- Evidence of residual, recurrent, or metastatic disease at randomization
- Active or history of autoimmune disease or immune deficiency
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
- Diagnosed additional malignancy within 5 years prior to baseline, except for: (a) non-invasive carcinomas subject to successful curative treatment in the opinion of the investigator which require no further therapy and (b) other malignancies for which subjects have undergone potentially curative therapy and have been considered disease free for at least 3 years prior to screening.
- Active infection requiring systemic therapy
- Is pregnant, breastfeeding or expecting to conceive or father children within the study's projected duration
- History of human immunodeficiency virus (HIV) (HIV I/II antibodies).
- Co-infection with HBV and hepatitis D viral infection
- Co-infection with HBV and HCV
- Has received a live vaccine within 30 days of planned start of study
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Personalized Immunotherapy for Cancer:
GNOS-PV02 + INO-9012 ID followed by electroporation every 3 weeks for 4 doses, then every 9 weeks (Q9W) until week 104, then every 12 weeks (Q12W) until week 260 followed by 3 years follow-up survival
|
delivered by intradermal injection and electroporation
GNOS-PV02 + INO-9012 ID followed by electroporation
cytokine interleukin-12 (IL-12), a vaccine adjuvant
|
|
无干预：Standard of Care
Active Surveillance for 5 years or until recurrence, plus 3 years follow-up survival.
|
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 |
|---|---|---|
|
Recurrence-free survival
大体时间：Up to 5 years
|
RFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary HCC, as assessed by the investigator, or death due to any cause, whichever occurs first.
|
Up to 5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to extra-hepatic spread or macro-vascular invasion
大体时间：Up to 5 years
|
Time to extra-hepatic spread or macro-vascular invasion (TTEHS/MVI)
|
Up to 5 years
|
|
Overall survival
大体时间：Up to 5 years on study + 3 years follow up
|
OS is defined as time from randomization to death of any cause
|
Up to 5 years on study + 3 years follow up
|
|
Incidence of treatment emergent adverse events (safety and tolerability)
大体时间：Up to 5 years
|
Summary adverse events according to CTCAE 6.0
|
Up to 5 years
|
|
RFS rate at 12, 18 and 24 months as assessed by the investigator
大体时间：Randomization up to 12 months, 18 and 24 months
|
The proportion of patients who remain free from disease recurrence after treatment over a specified period
|
Randomization up to 12 months, 18 and 24 months
|
|
RFS rate at 12, 18 and 24 months as assessed by the BIRC
大体时间：Randomization up to 12 months, 18 months and 24 months
|
The proportion of patients who remain free from disease recurrence after treatment over a specified period
|
Randomization up to 12 months, 18 months and 24 months
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (估计的)
2026年9月1日
初级完成 (估计的)
2029年9月1日
研究完成 (估计的)
2032年6月1日
研究注册日期
首次提交
2026年7月20日
首先提交符合 QC 标准的
2026年7月20日
首次发布 (实际的)
2026年7月23日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GT-31
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
IPD 计划说明
At the time of registration, the sponsor has not yet determined whether de-identified individual participant data collected during the study will be shared.
A decision regarding data sharing will be made following study completion and in accordance with sponsor policies, applicable regulations, and ethical considerations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
是的
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.