A phase 1 study of a combination chemotherapy, Sorafenib and intrahepatic arterial infusion of IA-call® (DDP-H), for advanced hepatocellular carcinoma.

Phase 1

• Conditions: Hepatocellular carcinoma

• Registration Number: JPRN-UMIN000003831
• Lead Sponsor: iigata Hepatocellular Carcinoma Therapy Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-07-01
• Study Completion: 2011-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

1)Pleural effusion and/or ascites refractory to treatments. 2)Comorbidity: a)Hyper tension over 100mmHg of diastolic blood pressure under medication. b)Uncontrollable heart failure, angina pectoris or arrhythmia. c)Myocardial infarction within 6 months. d)Brain metastasis. e)Active infectious diseases except for hepatitis. f)Active bleeding from GI tract. g)Active concomitant cancer with invasive nature. h)Severe mental disorder or hepatic encephalopathy. 3)A history of severe allergic reaction against iodine contrast medium and/or platinum agents. 4)A pregnant or lactating female or female of childbearing age unless using effective contraception. 5)Ongoing interferon therapy. 6)Difficulties of oral intake. 7)Other serious conditions judged to be inadequate by a responsible doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified