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

Phase 1

• Conditions: Hepatocellular carcinoma

• Registration Number: JPRN-UMIN000034371
• Lead Sponsor: niversity of Tsukuba

Brief Summary

Balloon-occluded alternate infusion transarterial chemoembolization is safe and effective for achieving a high ORR while preserving liver function.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-29
• Study Completion: 2020-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified