A Study of Sintilimab Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma
2020年6月22日 更新者:Xin-Hua Xu
a Phase II, Open-label, Single Arm Study of Sintilimab (an Anti-PD-1 Inhibitor) Combined With Apatinib and Capecitabine in Advanced Hepatocellular Carcinoma
This study aims to evaluate the efficacy and safety of Sintilimab (an Anti-PD-1 Inhibitor) combined with apatinib and capecitabine as first-line therapy in patients with advanced hepatocellular carcinoma.
研究概览
研究类型
介入性
注册 (预期的)
46
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:Lu Xu, Phd
- 电话号码:+8613972032135
- 邮箱:xlnick@qq.com
学习地点
-
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Hubei
-
Yichang、Hubei、中国、443003
- 招聘中
- Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
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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 至 75年 (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:
- Patient has given written informed consent.
- Age between 18-75 years old.male or female.
- Conform to the clinical diagnosis standard strictly or histological or cytological confirmation of HCC(hepatocellular carcinoma) and with at least one measurable lesion by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to RECIST 1.1 standard.
- Subjects haven't received any systemic treatment that includes target-therapy, immunotherapy or chemotherapy for HCC before admission.
- liver function status Child-Pugh Class A; Barcelona Clinic Liver Cancer(BCLC) staging is stage B or C;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1;
- Expected survival ≥12 weeks
The main organ's function is normal and it should meet the following criteria(Excludes use of any blood components and cell growth factors during the screening period):
- Absolute neutrophil count≥1.5×109 /L
- Platelets≥80×109/L ;Hemoglobin≥9.0 g/dL; Serum albumin≥3g/dL
- Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN); ALT and AST≤1.5×upper limit of normal(ULN); AKP≤ 2.5×upper limit of normal(ULN)
- Thyroid stimulating hormone (TSH)≤1.0×upper limit of normal(ULN)(If abnormal, T3 and T4 levels should be examined at the same time)
- Serum creatinine ≤1.5×ULN or creatinine clearance > 50 mL/minute (using Cockcroft-Gault formula)
Exclusion Criteria:
- Patients must not have had prior treatment with Sintilimab or any other PD-L1 or PD-1 antagonists.
- Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed.
- Known history of hypersensitivity to any components of the Sintilimab formulation, or other antibody formulation.
- Active central nervous system (CNS) metastases with clinical symptoms (including cerebral edema, steroid requirement, or progressive disease).
- Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma).
- Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%.
- Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
- Coagulation abnormalities (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy. Patients with or previous with serious hemorrhage (bleeding > 30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack).
- Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc.
- Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
- History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA ≥10⁴ /ml or hepatitis C virus (HCV) RNA≥103 /ml or higher)
- Participated in other clinical trials, or finish other clinical trials within 4 weeks. Patients who may receive other anti-tumor systemic chemotherapy during the study.
- Patients who may receive vaccination during the study, or previous had vaccination within 4 weeks.
- Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.
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: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:Sintilimab+Apatinib+Capecitabine
=Drug: Sintilimab(i.v)+apatinib(p.o)+capecitabine(p.o)
|
Drug: Sintilimab 200mg (3mg/kg for underweight patients) intravenously, every 21 days for a cycle; Drug: Apatinib,250mg po qd, for continuous medication; Drug: Capecitabine,1000mg/m2 po bid, d1-d14, every 21 days for a cycle; |
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 |
---|---|---|
Objective Response Rate (ORR)
大体时间:1 year after the last patient's enrollment
|
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
|
1 year after the last patient's enrollment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Disease Control Rate (DCR)
大体时间:1 year after the last patient's enrollment
|
Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
|
1 year after the last patient's enrollment
|
Duration of Response (DoR)
大体时间:1 year after the last patient's enrollment
|
Duration of Response (DoR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
|
1 year after the last patient's enrollment
|
Overall survival(OS)
大体时间:1 year after the last patient's enrollment
|
the date of Death of any causes since the date of enrollment
|
1 year after the last patient's enrollment
|
Progression-free survival(PFS)
大体时间:1 year after the last patient's enrollment
|
Progression-free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
|
1 year after the last patient's enrollment
|
Safety as measured by the rate of AEs
大体时间:1 year after the last patient's enrollment
|
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
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1 year after the last patient's enrollment
|
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
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 (实际的)
2020年6月21日
初级完成 (预期的)
2021年6月1日
研究完成 (预期的)
2022年6月1日
研究注册日期
首次提交
2020年5月28日
首先提交符合 QC 标准的
2020年5月28日
首次发布 (实际的)
2020年6月2日
研究记录更新
最后更新发布 (实际的)
2020年6月24日
上次提交的符合 QC 标准的更新
2020年6月22日
最后验证
2020年6月1日
更多信息
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.