JPRN-jRCTs031210114
Recruiting
Phase 2
Balloon-Occluded Trans-Arterial Chemo-Embolization Technique with Repeated Alternate Infusion of Cisplatin Solution and Sparse Gelatin Slurry (RAIB-TACE) for Hepatocellular Carcinoma refractory or intolerant to Atezolizumab plus Bevacizumab combination therapy
Hasegawa Naoyuki0 sites19 target enrollmentMay 26, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Hepatocellular Carcinoma
- Sponsor
- Hasegawa Naoyuki
- Enrollment
- 19
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients with hepatocellular carcinoma diagnosed by enhanced CT or MRI
- •2\. Hepatocellular Carcinoma refractory or intolerant to combination of atezolizumab and bevacizumab
- •3\. Age: 20 years or older
- •4\. ECOG Performance Status 0\-1
- •5\. Consent has been obtained from the patient.
- •6\. The patient is expected to survive for at least 3 months after treatment.
Exclusion Criteria
- •1\. Child pugh score over 8
- •2\. Renal failure (eGFR \<40\)
- •3\. Portal vein or Hepatic vein tumor thrombus
- •4\. More than 15cm tumor (the maximum tumor size)
- •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 distal metastasis
- •7\. Previous surgical biliary reconstruction.
- •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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