| General information |
| Database: | DB00155 |
| Objective: | Tremelimumab is a monoclonal antibody that blocks cytotoxic Tlymphocyteassociated antigen 4 (CTLA4), an inhibitory coreceptor that interferes with T cell activation and proliferation. The purpose of this pilot clinical trial was to test the antitumor and antiviral effect of tremelimumab in patients with hepatocellular carcinoma (hepatocellular carcinoma) and chronic hepatitis C virus (HCV) infection; and to study the safety of its administration to cirrhotic patients. |
| Authors: | Sangro B, et al |
| Title: | A clinical trial of CTLA4 blockade with tremelimumab in patients with hepatocellular carcinoma and chronic hepatitis C. |
| Journal: | J Hepatol |
| Year: | 2013 |
| PMID: | 23466307 |
| Trial Design |
| Clinical Trial Id: | NCT01008358. |
| Agent: | tremelimumab
|
| Target: | cytotoxic Tlymphocyteassociated antigen 4 (CTLA4)
|
| Cancer Type: | liver cancer |
| Cancer Subtype: | hepatocellular carcinoma and chronic hepatitis C |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | an investigatorinitiatedphase II, noncontrolled, openlabel, multicenter clinical trial |
| Key Patients Feature: | Patients 18 years of age or older were enrolled in the study if they had inoperable hepatocellular carcinoma confirmed by biopsy or noninvasive criteria and chronic HCV infection, their functional status was ChildPugh class A or B, and the disease was not amenable to percutaneous ablation or transarterial therapy. Patients previously treated with sorafenib, systemic chemotherapy, or recruited into another clinical trial could be enrolled after a washout period of at least 4 weeks. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Tremelimumab at a dose of 15 mg/kg IV every 90 days was administered until tumor progression or severe toxicity. Twenty patients were assessable for toxicity and viral response and 17 were assessable for tumor response. Most patients were in the advanced stage and 43% had an altered liver function (ChildPugh class B). |
| Primary End Point: | safety and efficacy |
| Secondary End Point: | NA |
| Patients Number: | 37 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Partial response rate was 17.6% |
| Disease Control Rate: | disease control rate was 76.4% |
| Median Time to Progression: | 6.48 months (95% CI 3.959.14). |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 8.2 months (95% CI 4.64-21.34) |
| Adverse Event(agent arm): | shown in table 2. (Clinical and laboratory adverse events according to CTCAE v 3.0) |
| Conclusions: | Tremelimumab safety profile and antitumor and antiviral activity, in patients with advanced hepatocellular carcinoma developed on HCVinduced liver cirrhosis, support further investigation. |