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Randomized phase II study comparing transcatheter arterial chemo-embolization with Miriplatin and transcatheter arterial chemo-embolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma

Randomized phase II study comparing transcatheter arterial chemo-embolization with Miriplatin and transcatheter arterial chemo-embolization with a fine-powder formulation of cisplatin for hepatocellular carcinoma - Comparing TACE with Miriplatin and TACE with DDPH for hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008719
Enrollment
400
Registered
2012-08-18
Start date
2010-01-01
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

Miriplatin-TACE group We used Miriplatin(Miripla, Dainippon-Sumitomo Pharmaceutical Co. Ltd., Osaka, Japan) mixed with LPD (iodized oil
Andre Guerget, Aulnay-sous-Bois, France). The Miriplatin-LPD suspension was prepared by mixing 70 mg of DDPH into 3-10 mL of LPD. The dosage of LPD and the anticancer drugs was adjusted depending
Nipponkayaku, Tokyo, Japan) mixed with contrast medium. DDPH-TACE group We used DDPH(IA-call
Nipponkayaku, Tokyo, Japan) mixed with LPD (iodized oil
Andre Guerget, Aulnay-sous-Bois, France). The DDPH-LPD suspension was prepared by mixing 50 mg of DDPH into 3-10 mL of LPD. The dosage of LPD and the anticancer drugs was adjusted depending on the

Sponsors

Iwate Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligibility criteria 1) No indication for surgical resection or local ablation therapy such as RFA and PEI therapy; 2) No evidence of extra hepatic metastasis; 3) No tumor thrombus in the main trunk of portal vein. 4) No evidence of active heart or renal diseases meeting the contraindications for ADM and CDDP therapy, respectively; 5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) [22] level 0-2; 6) Hypervascular tumors showing enhancement during angiography; 7) Bidimensionally measurable hepatic lesions; 8) No uncontrolled ascites or pleural effusion; 9) Total serum bilirubin (T-Bil) less than 3 mg/dL.

Exclusion criteria

Exclusion criteria: Exclusion criteria 1) Pregnancy woman 2) Patients who had allergic and severe disease

Design outcomes

Primary

MeasureTime frame
The primary efficacy endpoint of the current study is the objective response rate.

Countries

Japan

Outcome results

None listed

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