A Pilot Study of Tremelimumab - A Monoclonal Antibody Against CTLA-4 in Combination With Trans-Arterial Catheter Chemoembolization (TACE), Radiofrequency Ablation (RFA), or Cryoablation in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Number of Participants With Serious and Non-Serious Adverse Events Regardless of Attribution
研究概览
简要总结
Background:
- Tremelimumab is a cancer treatment drug that helps the immune system recognize and destroy cancer cells. Researchers want to see if it can be used to treat advanced liver cancer. The drug will be given with one of two types of treatment for liver cancer. The first type, transarterial catheter chemoembolization (TACE), injects chemotherapy drugs into the tumor through the main blood vessel that is feeding it. That blood vessel is then closed off to help keep the drugs in the tumor longer. The second type, radiofrequency ablation (RFA), uses a heated probe to destroy the tumor tissue. Researchers want to study how safe and effective these treatments are with the study drug.
Objectives:
- To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver cancer.
Eligibility:
- Individuals at least 18 years of age who have advanced liver cancer that has not responded to other treatments.
详细描述
Background:
Worldwide, hepatocellular carcinoma (HCC) is the fifth most common malignancy with a median survival of 6-9 months. For patients with advanced disease sorafenib is the only approved drug and this has limited benefit.
Tremelimumab is a monoclonal antibody against cytotoxic T-lymphocyte-associated protein 4 (CTLA4). Anti-CTLA4 therapy has been shown to enhance anti-tumor immunity by blocking tumor-induced immune suppression of cytotoxic T cells.
Various tumor ablative procedures and techniques have been shown to result in immunogenic cell death and induction of a peripheral immune response. Both transarterial catheter chemoembolization (TACE) and radiofrequency ablation (RFA) have been shown to do this, as well as cryoablation and external beam radiation.
The underlying hypothesis of this study is that the effect of anti-CTLA4 treatment can be enhanced by TACE or RFA in patients with advanced hepatocellular carcinoma. We will also evaluate this in the context of cryoablation and radiation in hepatocellular carcinoma (HCC) and RFA in cholangiocarcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pilot 1/Arm A1-Tremelimumab + RFA or TACE
Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: RFA (Procedure)
6/Arm E - Tremelimumab + RFA
Tremelimumab + Radiofrequency Ablation (RFA)
干预措施: RFA (Procedure)
Pilot 1/Arm A1-Tremelimumab + RFA or TACE
Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: Tremelimumab (Drug)
Pilot 1/Arm A1-Tremelimumab + RFA or TACE
Escalating doses of Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: TACE (Procedure)
2/Arm A2 - Tremelimumab + RFA or TACE
Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: Tremelimumab (Drug)
2/Arm A2 - Tremelimumab + RFA or TACE
Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: RFA (Procedure)
2/Arm A2 - Tremelimumab + RFA or TACE
Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: TACE (Procedure)
3/Arm B - Tremelimumab + TACE
Tremelimumab + Transarterial Catheter Chemoembolization (TACE)
干预措施: Tremelimumab (Drug)
3/Arm B - Tremelimumab + TACE
Tremelimumab + Transarterial Catheter Chemoembolization (TACE)
干预措施: TACE (Procedure)
4/Arm C (never opened)
Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: Tremelimumab (Drug)
4/Arm C (never opened)
Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: TACE (Procedure)
4/Arm C (never opened)
Tremelimumab + Radiofrequency Ablation (RFA) or Transarterial Catheter Chemoembolization (TACE)
干预措施: Cryoablation (Procedure)
5/Arm D - Tremelimumab + Cryoablation
Tremelimumab + Cryoablation
干预措施: Tremelimumab (Drug)
5/Arm D - Tremelimumab + Cryoablation
Tremelimumab + Cryoablation
干预措施: Cryoablation (Procedure)
6/Arm E - Tremelimumab + RFA
Tremelimumab + Radiofrequency Ablation (RFA)
干预措施: Tremelimumab (Drug)
结局指标
主要结局
Number of Participants With Serious and Non-Serious Adverse Events Regardless of Attribution
时间窗: Date treatment consent signed to date off study, approximately 44 months and 5 days for 1/Arm A1; 49 months and 26 days for 2/Arm A2; 1 month and 26 days for 3/Arm B; 30 months and 20 days for 5/Arm D; and 34 months and 25 days for 6/Arm E.
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
次要结局
- Number of Participants With Best Response(Start of study, baseline target lesions until disease progression occurs with 20% increase of target lesions or appearance of new lesions, up to 13.1 months)
- Progression Free Survival (PFS)(Progression free survival is time patients were off treatment until death. For all cohorts progression free survival ranged from 3.4 months to 8.6 months)
- Overall Survival(From the time of initial treatment consent until date of death for each patient. Overall survival ranged from 6 months to 13.1 months.)
研究者
Tim Greten, M.D.
Principal Investigator
National Cancer Institute (NCI)