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Safety assessment of repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for treatment of hepatocellular carcinomas.

Safety assessment of repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for treatment of hepatocellular carcinomas. - Assessment of RAIB-TACE for treatment of HCCs.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034371
Enrollment
50
Registered
2018-10-29
Start date
2018-11-01
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

repeated alternate infusion of cisplatin and gelatin fragments for balloon-occluded trans-catheter arterial chemo-embolization for hepatocellular carcinomas.

Sponsors

University of Tsukuba
Lead Sponsor
Mito Kyodo General Hospital Tsukuba Memorial Hospital Tsukuba Medical Center Hospital Japanese Red Cross Maebashi Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Diagnosis of hepatocellular carcinoma according to EASL guideline 2)Indication of TACE 3)over 20 year old and less 90 year old 4)ECOG Performance Status of 0 to 1 5)Informed consent is obtained. 6)promising over 3 month alive after treatment

Exclusion criteria

Exclusion criteria: 1)After rupture of HCC with shock vital 2)History of surgical or endoscopic biliary tract reconstruction 3)Dilation of segmental biliary tract 4)Lymph node metastases displacing biliary tract or portal vein 5)Prominent arterio-portal shunt or arterio-venous shunt 6)eGFR is under 50 ml/min/1.73m2 7)Child-Pugh score: over 7 score 8)History of TACE within 3 months in the area of therapeutic plan 9)Hepatic encephalopathy or severe psychic disturbance 10)Severe drug allergy including iodine contrast medium or other drugs 11)Inadequate patients to undergo the procedure safely 12) Tumor invades main or first branch of portal vein

Design outcomes

Primary

MeasureTime frame
Safety of RAIB-TACE

Secondary

MeasureTime frame
Tumor response based on RECICL criteria

Countries

Japan

Contacts

Public ContactSodai Hoshiai

University of Tsukuba Faculty of Medicine

hoshiai@md.tsukuba.ac.jp029-853-2111

Outcome results

None listed

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