The effect of Sorafenib and intermittent hepatic arterial infusion chemotherapy using Cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombus : a phase 1 study

The effect of Sorafenib and intermittent hepatic arterial infusion chemotherapy using Cisplatin for advanced hepatocellular carcinoma with portal vein tumor thrombus : a phase 1 study - The effect of Sorafenib and intermittent HAIC using CDDP for advanced HCC with PVTT : P-1 study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004107

Enrollment

Registered

2010-09-01

Start date

2010-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced hepatocellular carcinoma

Interventions

sorafenib:400mg (oral intake) for 28 days CDDP:20mg/m2 HAIC (day1,8,15)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with HCC 2.Above vp3 3.Child-Pugh A or B 4.ASA PS 0-1 5.WBC>3000/ul, Neutro>1500/ul, Hb>10.0g/dl, Platelet>75000/ul, T-Bil below 1.5 times higher than normal range, AST/ALT below 5 times higher than normal range, Creatinine below 1.5 times higher than normal range. 6.Beyond surgical indication 7.Patients that agree this study on document of informed concent

Exclusion criteria

Exclusion criteria: 1.Presence of metastasis 2.Presence of hepatic encephalopathy 3.Patients with active bacterial infection 4.Patients having blood vessel abnormality that difficult to insert hepatic arterial infusion port 5.Patients having severe disease 6.Patients losing of control over bowel movements 7.Patients with double cance 8.During pregnancy or breast-feeding woman 9.Contraindication of sorafenib or cisplatin

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity, Recommended dose	—

Secondary

Measure	Time frame
Adverse event rate, Response rate	—

Countries

Japan

Contacts

Public ContactMorihiko Ishizaki

Kansai Medical University Hirakata Hospital Department of surgery

ishizakm@hirakata.kmu.ac.jp072-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026