Prospective study of efficacy, safety and pharmacokinetics of transcatheter arterial chemoembolization (TACE) with miriplatin for hepatocellular carcinoma.

Phase 2

• Conditions: Hepatocellular carcinoma (HCC)

• Registration Number: JPRN-UMIN000006926
• Lead Sponsor: Kawasaki Medical School

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-21
• Study Completion: 2015-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1)History of malignant tumor 2)Serious and active infection, except for HBV and HCV 3)History of HIV infection 4)Renal dialysis 5)Diffuse tumor lesion 6)Extrahepatic metastasis 7)Vascular invasion 8)Intracranial tumor 9)Clinically uncontrolled ascites or pleural effusion 10)Clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment 11)Esophageal and/or gastric varices which has high risk of bleeding 12)History of thrombosis and/or embolism within 6 months of the start of treatment 13)History of receiving any of the following therapies: a)Systemic chemotherapy for advanced HCC b)Local therapy within 3 months of the start of treatment c)Invasive surgery within 4 weeks of the start of treatment d)History of allogenic transplantation e)History of bone marrow transplant or haemopoietic stem cell transplant within 4 weeks of the start of this study 14)Concurrent disease or disability that may affect evaluation of the effects of the study drugs 15)Enrollment in another study within 4 weeks of study entry 16)Female patients who are pregnant, lactating, possibly pregnant, or planning to become pregnant 17)Risk of allergic reactions to the study drugs 18)Drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results 19)Any condition that could jeopardize the safety of the patient or their compliance in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor response (Treatment effect: TE)

Secondary Outcome Measures

Name	Time	Method
Tumor marker change, overall survival, safety, pharmacokinetics (plasma Pt conc.)