Hepatocellular Carcinoma (HCC) Clinical Trial
Official title:
CSR02-Fab-TF as Hepatic Intra-arterial Therapy in Intermediate Stage B or Limited Advanced Stage C Hepatocellular Carcinoma (HCC): Dose-Escalation Study to Assess Safety and Tolerability
Intra-arterial (IA) therapy is generally used to treat HCC tumors that are too extensive to excise or treat with potentially curative local therapy. IA therapy takes advantage of the fact that the blood supply of HCC comes predominantly from the hepatic artery compared with the surrounding normal liver which is predominantly supplied by portal venous blood. The intent is to deprive the HCC of its blood supply, leading to the death of the tumor. Traditionally, various methods have been used to block the HCC blood supply, but improvements are needed. This study will investigate a new agent designed in the laboratory to block only tumor blood vessels, not blood vessels in the normal liver.
Genetic testing was done to identify differences between HCC tumors and normal liver, and a protein, PLVAP, was shown to be present on the blood vessels of HCC but not on the blood vessels of normal liver. An antibody, CSR02, was made that recognizes PLVAP and then the Fab portion of that antibody was combined with tissue factor, a normal human protein that initiates the clotting cascade. The result is a manufactured (recombinant) protein called CSR02-Fab-TF. Preclinical studies in a mouse model showed that infusion of an equivalent mouse protein resulted in the necrosis (death) of a transplanted human HCC. The current study is designed first, to identify a safe and optimal dose of CSR02-Fab-TF in patients , and then second, to determine the response rate of HCC tumors to the IA administration of CSR02-Fab-TF. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03007212 -
Outcome of Transarterial Chemo-embolization (TACE) in Hepatocellular Carcinoma Patients With Partial Portal Vein Thrombosis
|
Phase 4 | |
| Terminated |
NCT03236649 -
The Phase III Study of Icaritin Versus Sorafenib in PD-L1 Positive Advanced Hepatocellular Carcinoma Subjects
|
Phase 3 | |
| Withdrawn |
NCT04044326 -
The Safety and Efficacy of Spherical Microwave Ablation for the Treatment of Malignant Liver Tumors
|
N/A | |
| Recruiting |
NCT04687969 -
Multimodal Machine Learning Characterization of Solid Tumors
|
||
| Completed |
NCT02562755 -
Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone
|
Phase 3 | |
| Withdrawn |
NCT02406508 -
Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC
|
Phase 2 | |
| Completed |
NCT01972672 -
The Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT01247298 -
A Pilot Study of Trans Arterial Chemoembolization (TACE), Followed by Stereotactic Radiation Therapy (SBRT) for Patients With Hepatocellular Carcinoma
|
Phase 0 | |
| Completed |
NCT03735628 -
An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT02188901 -
Contrast (Sonazoid)-Enhanced US as a Screening Tool for Hepatocellular Carcinoma in Cirrhosis: An Exploratory Cross-sectional Study
|
N/A | |
| Active, not recruiting |
NCT04522908 -
Dose Escalation Study of Cabozantinib for Advanced HCC Patients With Preserved Liver Function
|
Phase 2 | |
| Terminated |
NCT01433016 -
Detection of Hepatocellular Carcinoma (HCC) With Octanoate Breath ID Test Compared to MRI
|
Phase 2 | |
| Withdrawn |
NCT04465734 -
A Clinical Study to Compare the Efficacy and Safety of HLX10 in Combination With HLX04 Versus Sorafenib as the First-line Treatment in Patients With Locally Advanced or Metastatic HCC
|
Phase 3 | |
| Recruiting |
NCT05057013 -
HMBD-001 in Advanced HER3 Positive Solid Tumours
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03753659 -
IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)
|
Phase 2 | |
| Terminated |
NCT03144661 -
An Open-Label Safety and Tolerability Study of INCB062079 in Subjects With Advanced Hepatocellular Carcinoma and Other Malignancies
|
Phase 1 | |
| Not yet recruiting |
NCT01821482 -
A Study of DC-CIK to Treat Hepatocellular Carcinoma
|
Phase 2 | |
| Completed |
NCT03516071 -
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
|
Phase 2 | |
| Completed |
NCT01761266 -
A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-line Treatment of Participants With Unresectable Hepatocellular Carcinoma
|
Phase 3 | |
| Not yet recruiting |
NCT06345001 -
A First-in-Human Study to Learn About How BAY3630942 is Distributed and Processed Inside the Body When Given After BAY3547922 and How Safe it is in People With Liver Cancer
|
Phase 1 |