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Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors.

Efficacy of postoperative hepatic arterial infusion chemotherapy with CDDP for hepatocellular carcioma with early recurrence risk factors. - adjubant CDDP TAI for HCC with high recurrence risk factors.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012041
Enrollment
60
Registered
2013-10-15
Start date
2013-10-15
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

Sponsors

Department of Gastroenterology and Metabolism,Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with curative hepatectomy 2) Patients with hepatocellular carcinoma diagnosed by histologial examination 3) Patients with early recurrence risk factors 4) Patients without recurrence 5) within 10 weeks after surgery 6) Male or female aged 20 years or older at the time of informed consent and younger than 85 years old 8) Patinets with chronic hepatitis or Child-Pugh class A, B cirrhosis 8) Patients with an ECOG Performance Status (PS) score of 0 or 1,2 9) Adequate organ function a.Neutrophil>=3000 /mm3 b.PLT>= 50000 /mm3 c.Hb>= 8.0g/dL d.T-Bil<= 3.0 mg/dL e.ALB>2.5g/dl f.AST<= within 5 times of normal limit ALT<= within 5 times of normal limit g.Cre<= within 1.5 times of normal limit h.PT>=40% i.No need of treatment on ECG 10) Life expectancy of at least 3 months 11) Patients obtained written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with mixed hepatocellular and cholangiocellular carcinoma diagnosed by histologial examination 2) Severe arterio-portal or arterio-venous shunts in the liver 3) Patinets with difficulty with drug arrival to hepatic lesion 4) Other uncontrolled severe illness a. With severe cardiac failure b. With severe renal function disease c. With active infectious disease except viral hepatitis d. With active gastrointestinal hemorrhage e. With active other malignancies f. With hepatic encephalopathy and severe mental disorder g. With clinically significant refractory ascites or pleural effusion 5) Allergic reaction to iodine contrast material, gadolinium contrast material, or platium containing agent. 6)Patients medicated with steroid 7) A pregnant woman, or a woman suspected of pregnancy. 8) Patients who are concluded to be inappropriate to participate in this study by their physitians

Design outcomes

Primary

MeasureTime frame
2 years recurrence rate

Countries

Japan

Contacts

Public ContactHiroshi Aikata

Hiroshima University Hospital Department of Gastroenterology and Metabolism

aikata@hiroshima-u.ac.jp082-257-5191

Outcome results

None listed

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