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A phase II clinical trial of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma greater than 30mm

A phase II clinical trial of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma greater than 30mm - A phase II clinical trial of carbon-ion radiotherapy using 4 fractions for hepatocellular carcinoma greater than 30mm

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013538
Enrollment
35
Registered
2014-04-01
Start date
2014-04-01
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

Carbon-ion beam Total dose 60.0 GyE 4 fractions

Sponsors

SAGA HIMAT foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The patient with single liver tumor diagnosed hepatocellular carcinoma pathollogically or clinically. 2) The tumor is measurable and the maximum diameter of the tumor is greater than 30mm. 3) cN0M0 (accrdiong to UICC(International Union Against Cancer) TMN classification of Malignant tumours 7th edition) 4) The Child-Pugh score of the patient is from 5 points to 8 points. 5) Perfomance status of the patient is from 0 to 2. 6) Life expectancy of the patients is longer than one year. 7) The patient is able to understand the explanation of the clinical trial and written informed concent is obtained.

Exclusion criteria

Exclusion criteria: 1) Patient have recieved any other therapies for hepatocellular carcinoma. 2) The alimentary tract is included in the planning target volume. 3) Patient with ascites. 4) Patient with hepatic encephalopathy. 5) Patient with sever paraesophageal varix or portal hypertention. 6) Patient with intractable esophageal or gastric varix. 7) Patients with any other active malignancies. 8) Patients with active and intractable infection at the same position where carbon-ion radiotherapy is planned.

Design outcomes

Primary

MeasureTime frame
3-year overall survival 3-year cause-specific survival

Secondary

MeasureTime frame
3-year local control rate Normal tissue reaction

Countries

Japan

Contacts

Public ContactShingo Toyama

SAGA HIMAT foundation Ion Beam Therapy Center

toyama-shingo@saga-himat.jp0942-81-1897

Outcome results

None listed

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