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Late phase II clinical study of intra-arterial chemotherapy using SM-11355 in patients with hepatocellular carcinoma (HCC) .

Late phase II clinical study of intra-arterial chemotherapy using SM-11355 in patients with hepatocellular carcinoma (HCC) .

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220093
Enrollment
Unknown
Registered
2005-09-12
Start date
2005-09-12
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

investigational material(s) Generic name etc : SM-11355 (Miriplatin Hydrate) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for In

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -HCC confirmed histologically and/or clinically diagnosed by angiography and CT -Hypervascular HCC -Not indicated for hepatectomy, PEI, PMCT and RFA -Stage II or III (Liver Cancer Study Group of Japan: Classification of primary liver cancer) -ECOG performance status (PS) of 0, 1 or 2 -Aged 20 to less than 75 etc. -Patients with a history of severe allergy to iodine-containing drugs and/or contrast media -Severe complication (especially severe thyroid or heart disease) -Active malignancies of other organs etc.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy: TEVrate (TE: therapeutic effect, the criteria for evaluation of direct effects on liver carcinoma, prepared by the Committee for Preparing Criteria for Evaluating the Effects of Multidisciplinary Treatment of Liver Cancer of the Japanese Society of Liver Carcinoma)—

Outcome results

None listed

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