NCT01853618

Tremelimumab With Chemoembolization or Ablation for Liver Cancer

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Heptocellular Cancer
• Biliary Tract Neoplasms
• Liver Cancer
• Hepatocellular Carcinoma
• Biliary Cancer

Interventions

Type	Name	Description
DRUG	Tremelimumab	3.5 mg/kg or 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years
PROCEDURE	RFA	Performed on Day 36
PROCEDURE	TACE	Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)
PROCEDURE	Cryoablation	Performed on Day 36

Timeline

• Start date: 2013-05-02
• Primary completion: 2017-06-07
• Completion: 2017-06-07
• First posted: 2013-05-15
• Last updated: 2019-12-10
• Results posted: 2019-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study