Tremelimumab With Chemoembolization or Ablation for Liver Cancer
Condition: Heptocellular Cancer; Biliary Tract Neoplasms; Liver Cancer; Hepatocellular Carcinoma; Biliary Cancer
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms; Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Intervention name(s): Tremelimumab; RFA; TACE; Cryoablation
Intervention type(s): Drug; Procedure; Procedure; Procedure
Intervention description(s): 3.5 mg/kg or 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years; Performed on Day 36; 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); Performed on Day 36
Other intervention name(s): Ticilimumab; Radiofrequency Ablation; Transarterial Catheter Chemoembolization
Intervention MeSH terms: Tremelimumab
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blocking of Immune Suppression; Monoclonal Antibody; Immunotherapy; Ablative Therapy