Evaluation of efficacy to combine transarterial chemoembolization and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma

Evaluation of efficacy to combine transarterial chemoembolization and intrahepatic arterial infusion of DDP-H for hepatocellular carcinoma - Efficacy of TACE/hepatic arterial infusion of DDP-H combination in HCC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002428

Enrollment

160

Registered

2009-09-14

Start date

2009-09-01

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

Hepatocellular carcinoma

Interventions

TACE alone TACE + intrahepatic arterial infusion of DDP-H

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) A proper indication for TACE according to Japan HCC management guideline 2) Japan integrated stage scores 2 or 3 3) Child-Pugh A or B 4) No active cancers except for HCC 5) Performance status (ECOG) 0, 1 or 2 6) Satisfying following serum biochemistries before therapy WBC 3,000 /micro litter=< Platelet 50,000 /micro litter=< Hb 8.0 g/dl=< Total bilirubin 3.0 g/dl=> Creatinine clearance 50ml/min=< (after adjustment to 1.73m2 of body surface area) 7) No anti-cancer treatments affecting the liver except for the RFA target 8) Agreement to be enrolled in a form of informed consent

Exclusion criteria

Exclusion criteria: 1) Severe allergic history for iodine and platinum drug 2) Pregnant, possibility of pregnancy, or feeding a baby 3) Vascular involvement Vp3, Vv3 or more 4) Under interferon therapy 5) Other factors that a responsible doctor judged to be unsuitable

Design outcomes

Primary

Measure	Time frame
1) Primary endpoint, the time when a classical HCC is confirmed by several imaging modalities in the liver except for the vicinity to the TACE area. 2) Secondary endpoint, allover survival	—

Secondary

Measure	Time frame
Tumor markers of AFP, DCP and other serum biochemistries.	—

Countries

Japan

Contacts

Public ContactAkihiko Ohsaki

Niigata Hepatocellular Carcinoma Therapy Study Group Excutive office

tm98020ao-nii@umin.ac.jp025-227-2207

Outcome results

None listed

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