派姆单抗联合曲妥珠单抗和化疗治疗食管胃癌的研究
新辅助 Pembrolizumab 联合曲妥珠单抗和化疗治疗可切除 HER2+ 食管胃肿瘤的单臂、多中心 2 期研究
The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.
研究概览
地位
详细说明
Eligible patients will receive 8 peri-operative cycles of pembrolizumab and trastuzumab with chemotherapy (fluoropyrimidine/oxaliplatin doublet for patients initially enrolled and subsequently FLOT [5-fluorouracil, oxaliplatin and docetaxel] followed by pembrolizumab and trastuzumab maintenance to complete 1 total year of therapy.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习联系方式
- 姓名：Yelena Janjigian, MD
- 电话号码：646-888-4186
- 邮箱：janjigiy@mskcc.org
研究联系人备份
- 姓名：Samuel Cytryn, MD
- 邮箱：cytryns@mskcc.org
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital (Data Collection Only)
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接触：
- Samuel Klempner, MD
- 电话号码：617-724-4000
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New Jersey
-
Basking Ridge、New Jersey、美国、07920
- 招聘中
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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接触：
- Yelena Janjigian, MD
- 电话号码：646-888-4186
-
Middletown、New Jersey、美国、07748
- 招聘中
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
-
接触：
- Yelena Janjigian, MD
- 电话号码：646-888-4186
-
Montvale、New Jersey、美国、07645
- 招聘中
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
接触：
- Yelena Janjigian, MD
- 电话号码：646-888-4186
-
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New York
-
Commack、New York、美国、11725
- 招聘中
- Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
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接触：
- Yelena Janjigian, MD
- 电话号码：646-888-4186
-
Harrison、New York、美国、10604
- 招聘中
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
-
接触：
- Yelena Janjigian, MD
- 电话号码：646-888-4186
-
New York、New York、美国、10065
- 招聘中
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
接触：
- Yelena Y Janjigian, MD
- 电话号码：646-888-4186
-
Uniondale、New York、美国、11553
- 招聘中
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
-
接触：
- Yelena Janjigian, MD
- 电话号码：646-888-4186
-
-
Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- 主动，不招人
- University of Pennsylvania (Data Collection Only)
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Texas
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Houston、Texas、美国、77030
- 招聘中
- MD Anderson Cancer Center (Data Collection Only)
-
接触：
- Jennifer Li, MD
- 电话号码：855-760-5921
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 18 years or older at time of signing informed consent.
- ECOG performance status 0-1.
- HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH>2.0 expression.
- Complete surgical resection of the primary tumor must be achievable
- Demonstrate adequate organ function as defined in Table 1.
Table 1 - Organ Function Requirements for Eligibility Hematological
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Absolute neutrophil count (ANC): ≥1,500 /mcL
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Platelets: ≥100,000 / mcL
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Hemoglobin: ≥8 g/dL Renal
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Creatinine clearance: ≥ 50 mL/minute Hepatic
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Serum total bilirubin: ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN. Except patients with Gilbert's disease (≤3x ULN)
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AST and ALT: ≤ 2.5 X ULN
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Albumin: >3 mg/dL Coagulation
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International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT): <1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
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Male participants: A male participant must agree to use contraception as detailed in Section 15.3 of this protocol during the treatment period and for at least 230 days (5 terminal half-lives of trastuzumab [140] plus an additional 90 days [spermatogenesis cycle]) after the last dose of study treatment and refrain from donating sperm during this period.
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Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in section 15.3 OR
- A WOCBP who agrees to follow the contraceptive guidance in section 15.3 during the treatment period and for at least 170 days (140 days plus an additional 30 days [menstruation cycle]) after the last dose of study treatment.
Exclusion Criteria:
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Presence of metastatic or recurrent disease.
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Has received prior treatment for esophagogastric cancer
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Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.
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Has received prior therapy with an anti-HER2 agent
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Left ventricular ejection fraction <50% within 1 month of screening by MUGA or echocardiogram. Patients with an ejection fraction 45-49% may be permissible in the absence of any cardiac symptoms, if cleared by a cardiologist, and per the investigator's discresion.
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Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
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Has a 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 trial treatment.
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Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., dexamethasone containing antiemetic regimen or steroids as CT scan contrast premedication) may be enrolled.
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The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
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Has a known history of active TB (Bacillus tuberculosis)
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Hypersensitivity to pembrolizumab or any of its excipients
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Has been diagnosed or treated for another malignancy in the past 3 years (not including non-melanoma skin cancer)
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Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
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Has known history of, or any evidence of active, non-infectious pneumonitis.
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Has an active infection requiring systemic therapy.
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Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
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Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
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A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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Has had an allogeneic tissue or solid organ transplant
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Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
- Subjects with vitiligo or alopecia
- Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
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Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
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Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
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Is unwilling to give written informed consent, unwilling to participate, or unable to comply with the protocol for the duration of the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 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：Esophagogastric Cancer
Participants will have a diagnosis of resectable HER2+ (IHC 3+ or IHC 2+/FISH ratio >2.0) esophageal, GEJ or gastric cancer. |
Pembrolizumab will be administered on an every 3-week dosing schedule Trastuzumab will be administered on an every 3-week dosing schedule Oxaliplatin every 3 weeks, +/-7 days Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks 5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks Docetaxel administered intravenously once every 2 weeks. will be collected (optionally) will be collected (optionally) |
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 |
|---|---|---|
|
Event-free survival (EFS)
大体时间：2 years
|
EFS is defined as the time from start of treatment to time of disease progression, recurrence, or death, whichever occurs first. |
2 years
|
合作者和调查者
调查人员
- 首席研究员：Yelena Janjigian, MD、Memorial Sloan Kettering Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- 23-124
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.