Ignite Creation Date:
2024-05-06 @ 1:37 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01853618
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2013-05-02
Brief Title:
Tremelimumab With Chemoembolization or Ablation for Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
- 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
Detailed Description:
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
Objective
To assess the safety and feasibility of combining Tremelimumab with trans-arterial catheter chemoembolization TACE radiofrequency ablation RFA or cryoablation in patients with advanced HCC
Eligibility
Histologically or cytologically confirmed diagnosis of HCC
Childs-Pugh AB7 cirrhosis only is allowed If patient does not have cirrhosis this limitation does not apply
Barcelona Clinic Liver Cancer BCLC Stage B and C patients
Patients must have disease that is not amenable to potentially curative resection radiofrequency ablation or liver transplantation
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
Objective
To assess the safety and feasibility of combining Tremelimumab with trans-arterial catheter chemoembolization TACE radiofrequency ablation RFA or cryoablation in patients with advanced HCC
Eligibility
Histologically or cytologically confirmed diagnosis of HCC
Childs-Pugh AB7 cirrhosis only is allowed If patient does not have cirrhosis this limitation does not apply
Barcelona Clinic Liver Cancer BCLC Stage B and C patients
Patients must have disease that is not amenable to potentially curative resection radiofrequency ablation or liver transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13-C-0120 | None | None | None |