JPRN-jRCTs031200334
Completed
Phase 2
Balloon-Occluded Trans-Arterial Chemo-Embolization Technique with Repeated Alternate Infusion of Cisplatin Solution and Sparse Gelatin Slurry (RAIB-TACE) for the Patients with Hepatocellular Carcinoma beyond Up-to 7 Criteria - RAIB-TACE for the Patients with Hepatocellular Carcinoma beyond Up-to 7 Criteria
Hoshiai Sodai0 sites19 target enrollmentJanuary 29, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hoshiai Sodai
- Enrollment
- 19
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with hepatocellular carcinoma diagnosed by enhanced CT or MRI
- •2\. Up to seven criteria out
- •3\. need to treat two or more subsegmenta by TACE
- •4\. Age: 20 years or older.
- •5\. ECOG Performance Status: 0\-1
- •6\) Consent has been obtained from the patient.
- •7\) The patient is expected to survive for at least 3 months after treatment.
Exclusion Criteria
- •1\) Child\-Pugh score is greater than or equal to 7\.
- •2\) Renal function with an eGFR of less than 40\.
- •3\) Tumor throat in portal vein branch or main stem or hepatic vein.
- •4\) The largest tumor is greater than or equal to 15 cm in diameter.
- •5\) Sarcomatous changes (over the course of 2\-3 months, the tumor size increases 1\.5\-2 times or more in size and there is no increase in arterial blood flow. Alternatively, there is a ring of staining with irregular margins and no capsule structure and internal necrosis.
- •6\) Lymph node involvement or distant metastasis.
- •7\) Previous surgical biliary reconstruction or endoscopic bile duct treatment.
- •8\) Dilation of bile ducts larger than the diameter of the accompanying portal vein at the level of the area or higher.
- •9\) A severe arterial\-portal or arterial\-venous shunt is present.
- •10\) Severe mental impairment.
Outcomes
Primary Outcomes
Not specified
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