Clinical Trials Logo

Clinical Trial Summary

The aim of the study was to evaluate the safety and efficacy of using the new formulation (Lipiodol-cisplatin suspension) for TACE in the treatment of HCC as compared to the conventional formulation (Lipiodol-cisplatin emulsion). This is a prospective, parallel-group, open-label randomized, phase II study that is conducted in accordance to the Declaration of Helsinki and international standards of Good Clinical Practice, and approved by the institutional review board. Eligible patients were randomized into either a treatment arm of Lipiodol-cisplatin suspension or a control arm of Lipiodol-cisplatin emulsion with a 1:1 ratio.


Clinical Trial Description

Transcatheter arterial chemoembolization (TACE) has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic lesions not eligible for surgical resection, transplantation, or local ablative therapy. In Hong Kong, the TACE regimen currently being utilized in the great majority of hospitals is based on an aqueous form of cisplatin (1mg per mL) mixed in a one-to-one ratio by volume with Lipiodol to form a relatively large volume of 40mL emulsion at 20mg cisplatin as the maximum dose. Although TACE with this regimen has been shown to be effective in prolonging overall survival, there is probably room for further improvement because the objective tumor response rate is limited to 39%. One of the approaches to improve the treatment effectiveness of TACE could be to increase the dose of chemotherapeutic agent. In the United States, the most common regimen of chemotherapeutic agent in TACE is the mixture of cisplatin 100mg, doxorubicin 50mg, and mitomycin C 10mg, dissolved in 10ml of water-soluble contrast medium, then emulsified in an equivalent volume of lipiodol to form a 20mL emulsion. A relatively new regimen was introduced, in which a relatively high dose of cisplatin up to 100mg in particle form was given as a suspension in 20mL of Lipiodol, this regimen has been used and found to achieve an improved objective tumor response rate of 51%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03268499
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Completed
Phase Phase 2
Start date September 9, 2016
Completion date April 28, 2023

See also
  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
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
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 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
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2
Recruiting NCT05537402 - LOcoregional vs Systemic Therapy in Patients With BCLC Stage B HCC Phase 2