Hepatocellular Carcinoma Clinical Trial
Official title:
Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer
This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.
The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. Expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid tumors with liver metastasis, and (3) neuroendocrine tumor. Adverse events are evaluated by CTCAE vs. 5.0 and efficacy is evaluated by MRI using modified RECIST criteria and RECIST criteria. The dose escalation part has been completed. Only the third cohort or neuroendocrine tumor remains active for future patient enrollment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
| Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
| Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
| Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
| Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
| Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
| Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
| Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
| Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
| Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
| Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
| Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
| Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
| Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |