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Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma

Randomized controlled study to examine the efficacy of hepatic arterial infusion chemotherapy with cisplatin before radiofrequency ablation for hepatocellular carcinoma - Efficacy of HAIC with cisplatin before RFA for HCC

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007267
Enrollment
90
Registered
2012-02-11
Start date
2012-03-01
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

Hepatic arterial infusion chemotherapy with cisplatin and RFA RFA

Sponsors

Okayama University Hospital
Lead Sponsor
Department of Gastroenterology, Okayama City Hospital, Okayama, Japan Medical Center for Clinical and Translational Research, Hiroshima University Hospital, Hiroshima, Japan Department of Internal Medicine, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan Department of Internal Medicine, Fukuyama City Hospital, Hiroshima, Japan Department of Internal Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan Department of Gastroenterology, Mitoyo General Hospital, Kannonji, J
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with hepatocellular carcinoma diagnosed by histologial examination or by imaging modalities 2) Less than or equal to 3 lesions, 30 mm or less in diameter 3) No extra-hepatic metastasis 4) No vascular invasion 5) Patients in Child-Pugh Class A or B 6) Male or female aged 20 years or older at the time of informed consent and younger than 90 years old 7) Patients with an ECOG Performance Status (PS) score of 0 or 1 8) No prior chemotherapy 9) Adequate organ function a) Neutrophil>=1500 /mm3 b) Hb>= 8.5 g/dL c) PLT>= 50000 /mm3 d) T-Bil<= 2.0 mg/dL e) AST<= within 5 times of normal limit ALT<= within 5 times of normal limit f) Cre<= within 1.5 times of normal limit 10) Written informed consent 11) Life expectancy of at least 6 months

Exclusion criteria

Exclusion criteria: 1) Patients with histologically diagnosed mixed hepatocellular carcinoma or sarcomatoid carcinoma 2) History of any therapy to hepatocellular carcinoma 3) Patients unsuitable for RFA 4) Patients unsuitable for administration of CDDP 5) Patients who have simultaneous malignancies 6) Patients who have severe complications 7) Ascites or pleural effusion unresponsible to therapy 8) Patients inadequate in the investigator's judgement

Design outcomes

Primary

MeasureTime frame
Recurrence free survival—

Secondary

MeasureTime frame
Incidence of adverse events Time to treatment failure with RFA Evaluation of treatment effect with tumor markers—

Countries

Japan

Contacts

Public ContactKazuhiro Nouso

Okayama university hospital Department of gastroenterology

nouso@cc.okayama-u.ac.jp086-235-7219

Outcome results

None listed

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