Hepatocellular Carcinoma Clinical Trial
Official title:
A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients
Hepatocellular carcinoma (HCC) is a prevalent malignancy with great disease burden both in Taiwan and worldwide 1. Early stage HCC can be treated by surgical resection, radiofrequency ablation, embolization and liver transplantation. However, treatments for advanced HCC are still unsatisfactory. Systemic therapy is necessary for advanced HCC 2. Target therapy using sorafenib was established a decade ago, but its response rate is quite low (~3%), the adverse effects may be intolerable and it can only extend survival 2.3 to 2.8 months 3,4. Newly developed tyrosine kinase inhibitors (TKIs) include regorafenib 5, lenvatinib 6, cabozantinib 7 and ramucirumab 8. The single target therapy objective response rate is around 3-24%. Recently, immune checkpoint inhibitors (ICIs) emerged as a new hope for cancer therapy in various kinds of malignancies including HCC. These include CTLA4, PD-1 and PD-L1 blockades.
This is an open-label, phase I pilot study. A total of 10 patients will be recruited in National Taiwan University Hospital between October, 01, 2021 and December, 31 2023. All examinations and treatment will be performed at National Taiwan University Hospital. The inclusion criteria are Child-Pugh classification A, unresectable HCC patients with age more than 20 years-old and radiologically measurable disease that is at least 2 cm in longest dimension of the target tumor. ;
| 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 |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/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 |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
| Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |