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dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma

dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma - dose-finding study of miriplatin arterial injection therapy for advanced hepatocellular carcinoma

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000014961
Enrollment
9
Registered
2014-08-31
Start date
2014-09-01
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

hepatocellularcarcinoma

Interventions

intra-arterial injection of miriplatin suspension from the hepatic artery

Sponsors

tokushima university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients diagnosed with hepatocellular carcinoma clinical such as angiography, CT, and MRI or histologically Patients with off-label liver resection, PEI and RFA Patient had never received chemotherapy TAE. PEI or liver resection, RFA is acceptable. However, PEI , RFA and post-stump recurrence after hepatectomy I will improper local recurrence. Child Pugh A or B Patients must be expected to survive more than two months at least organ function below, the patient sufficient bone marrow, renal, cardiovascular is maintained. Liver has sufficient compensatory physiologically function. WBC or more 3,000 per micro litter PLT or more 50000/micro litter Hb or more 9.5g/micro litter AST or less 200 U/L ALT or less 200 U/L Serum bilirubin or less 3mg/dL Serum creatinine or less facility upper limit of normal Patients to confirm that it also has a structure of appropriate hepatic artery for catheter insertion selective the general state, Performance Status is of 0, 1, and 2 patients The elapsed more than 4 weeks at least from before treatment, liver resection, the RFA or PEI, patients without the influence of prior treatment

Exclusion criteria

Exclusion criteria: (1) Patients with a history of hypersensitivity to contrast agent or drug, including Iodine (2) Patients with (thyroid disease particularly severe, severe cardiac disease) complications (3) serious Patients with double cancer activity (4) Patients with intrahepatic shunt (5) Patients with distant metastases (6) Patients with intention of pregnancy, pregnant women, and lactating women (7) Patients with investigator or investigator was found to be inappropriate as a target

Design outcomes

Primary

MeasureTime frame
responce rate

Secondary

MeasureTime frame
The extent and frequency of occurrence of adverse events and survival rate

Countries

Japan

Contacts

Public Contacttanaka hironori

university of tokushima graduate school department of gastroenterology and oncology, instituteof health bioscience

takayama@tokushima-u.ac.jp088-633-7124

Outcome results

None listed

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