A clinical study on safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion chemotherapy (PIHP) for advanced hepatocellular carcinoma

A clinical study on safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion chemotherapy (PIHP) for advanced hepatocellular carcinoma - A safety and efficacy of sorafenib as maintenance chemotherapy after percutaneous isolated hepatic perfusion (PIHP) for advanced hepatocellular carcinoma

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008689

Enrollment

Registered

2012-09-19

Start date

2012-10-01

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

hepatocellular carcinoma

Interventions

After 4-8 weeks of PIHP, sorafenib therapy starts with a primary dose of 800mg/day. Sorafenib therapy continues until the appearance of unacceptable side effect or tumor progression.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients who underwent PIHP for advanced hepatocellular carcinoma 2)Patients who were diagnosed as hepatocellular carcinoma radiologically or pathologically 3)Patients who have no indication of surgical resection, local therapy (RFA, TACE, percutaneous ethanol injection) 4)Patients who satisfy the criteria of sorafenib administration 5)Patients who approve sorafenib therapy and sign a document for it.

Exclusion criteria

Exclusion criteria: 1)Patients with a history of molecular- target therapy including sorafenib. 2)Patients with a history of hypersensitivity of sorafenib 3)Patients who are pregnant or on nurse. 4)Patients who are on dialysis 5)Patients with uncontrolled hypertension 6)Patients with a history of thrombosis, embolism, or ischemic Heart Disease 7)Patients with brain metastasis 8)Patients with esophageal varix with bleeding tendency 9)Patients with gastrointestinal bleeding within one month 10)Patients with ongoing or history of hepatic encephalopathy 11)Patients who undergo rifampin 12)Patients with HIV or AIDS 13)Patients with synclonous double cancer

Design outcomes

Primary

Measure	Time frame
One year overall survival	—

Secondary

Measure	Time frame
Progression or recurrence free survival Overall survival Safety of sorafenib administration after PIHP	—

Countries

Japan

Contacts

Public ContactMotofumi Tanaka

Kobe University Department of hepato-biliary-pancreatic surgery

motofutanaka-gi@umin.net078-382-6302

Outcome results

None listed

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