Tremelimumab With Chemoembolization or Ablation for Liver Cancer
- 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.
- To test the safety and effectiveness of Tremelimumab with TACE or RFA for advanced liver cancer.
- Individuals at least 18 years of age who have advanced liver cancer that has not responded to other treatments.
Liver Cell Caricinoma
Procedure: Trans-Arterial Cather Chemoembolization
Procedure: Radiofrequency Ablation (RFA)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Tremelimumab, A Monoclonal Antibody Against CTLA-4, in Combination With Either Trans-Arterial Catheter Chemoembolization (TACE) or Radiofrequency Ablation (RFA) in Subjects With Hepatocellular Carcinoma (HCC)|
- Safety and feasibility of combining Tremelimumab with trans-arterial catheter chemoembolization (TACE) or radiofrequency ablation (RFA) in patients with advanced HCC. [ Time Frame: 4/10/13 to 12/31/2015 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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 CTLA4. Anti-CTLA4 therapy has been shown to enhance anti-tumor immunity by blocking tumor-induced immune suppression of cytotoxic T cells.
Both trans-arterial catheter chemoembolization (TACE) and radiofrequency ablation (RFA) have been shown to induce a peripheral immune response.
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.
To assess the safety and feasibility of combining Tremelimumab with trans-arterial catheter chemoembolization (TACE) or radiofrequency ablation (RFA) in patients with advanced HCC.
To evaluate the following in patients with advanced HCC undergoing TACE or radiofrequency ablation (RFA) in combination with Tremelimumab:
- changes in immune parameters in the peripheral blood
- clinical indicators of efficacy (response rate, time to tumor progression, overall survival)
Histologically or cytologically confirmed diagnosis of HCC.
Childs-Pugh A/B7 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.
|Contact: Suzanne Fioravanti, R.N.||(301) firstname.lastname@example.org|
|Contact: Tim F Greten, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Tim F Greten, M.D.||National Cancer Institute (NCI)|