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Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial

Stereotactic radiotherapy(SRT) combined with transcatheter arterial chemoembolization(TACE) for hepatocellular carcinoma: Phase II trial - SRT combined with TACE for HCC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000640
Enrollment
100
Registered
2007-04-01
Start date
2007-04-01
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

Stereotactic radiotherapy

Sponsors

Liver radiothrapy group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The patients are diagnosed as hepatocellular carcinoma with the following criterion of A or B, and the other inclusion criterion are the following 1-9. A.In patients with chronic HBV or HCV hepatitis, typical tumor appearances are needed in 3 phase enhanced CT or other dynamic images. B.In patients without chronic HBV or HCV hepatitis, pathological diagnosis is needed in first HCC and typical tumor appearances are needed in 3 phase enhanced CT or other dynamic images during follow-up after treatment of first HCC. 1.Three phase enhanced CT or other dynamic images is performed within 28 days. And the tumor maximal diameter is less than or equal to 4 cm (includes recurrence after another treatment, macroscopic residual tumor after resection, RFA or PEIT). 2.Ablation therapy is difficult or unable to perform because the tumors exist in the area such as subphrenic area and vicinity of portal vein, or the tumor shape is too complicated. 3.Surgery is out of indication or is suspected to lead poor liver function after surgery. 4.Radiation doses at organ at risk do not exceed the criterion based on the imaging study perfomed within 28 days. 5.Child-Pugh classification A or B. 6.Age older than or equal to 20 years. 7.ECOG-PS: 0-2. 8.Written approvement is given from the candidate.

Exclusion criteria

Exclusion criteria: 1.Active infectious disease needing treatment except for external application. 2.In or suspected pregnancy or breast-feeding 3.mental disease which prohibit the patients from understanding this trial. 4.successive steroid use ( oral or intra-venous administration).

Design outcomes

Primary

MeasureTime frame
Three year local pogression free survival

Secondary

MeasureTime frame
Three year overall survival Median overall survival Median overall progression free survival Median local progression free survival Median event free survival Type of progression Acute complication rate Chronic complication rate Severe complication rate

Countries

Japan

Contacts

Public ContactEtsuo Kunieda

Fuculty of Medicine, Tokai Univ. Department of Radiation Oncology

kunieda@tokai-u.jp0463-93-1121

Outcome results

None listed

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