The combination therapy of HAIC and RT for tumor thrombosis.

The combination therapy of HAIC and RT for tumor thrombosis. - The combination therapy of HAIC and RT for tumor thrombosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000012071

Enrollment

Registered

2013-10-18

Start date

2013-11-01

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 20 Years and older. 2) Life expectancy of at least 12 weeks at the pre-treatment evaluation. 3) Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or MRI. 4) Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization. 5) At least 4 weeks since last therapy for HCC. 6) Intrahepatic tumor which affects patient'prognosis. 7) Extrahepatic tumor apread which not affects patient's prognosis. 8) ECOG Performance status of 0 or 1. 9) Child-Pugh 5,6,7 10) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements: Granulocyte >= 3000/mm3 Platelet count >= 50,000 /mm3 Hemoglobin >= 8.5 g/dl Total serum bilirubin <= 3 mg/dl serum albimin>=2.8 Serum creatinine <= 1.5 mg/dl prothrombin consumption test>=50% Amylase <= 2 times upper limit of normal 11) Written Informed Consent must be obtained.

Exclusion criteria

Exclusion criteria: 1) With other malignant disease. 2) A pregnant woman, or a woman suspected of pregnancy. 3) With severe infectious disease. 4) With history of severe allergy. 5) With severe renal function disease. 6) With severe allergy for 5FU or CDDP. 7) With severe bone marrow supression. 8) Esophageal and/or gastric varices which has high risk of bleeding and clinically significant gastro- intestinal bleeding. 9) Serious hypertension 10) Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.

Design outcomes

Primary

Measure	Time frame
Local tumor control rate	—

Secondary

Measure	Time frame
Overall survival rate	—

Countries

Japan

Contacts

Public ContactHiroshi Aikata

Hiroshima university hospital Departments of Gastroenterology and Metabolismepartments of Gastroenterology and Metabolism

aikata@hiroshima-u.ac.jp082-257-5192

Outcome results