RAIB-TACE for Hepatocellular Carcinoma refractory or intolerant to Atezolizumab plus Bevacizumab

Phase 2

Recruiting

• Conditions: D006528; Hepatocellular Carcinoma; Hepatocellular Carcinoma, atezolizumab, bevacizumab, TACE

• Registration Number: JPRN-jRCTs031210114
• Lead Sponsor: Hasegawa Naoyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-26
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 19

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.
11. Severe allergy to iodine contrast medium or cisplatin.
12. Pregnant or lactating patients.
13. Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
14. Immune-related Adverse Events that require steroid administratin (more than 30mg/day of prednisolone)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of RAIB-TACE: Patient-based tumor reduction effect based on RECIST, a centrally judged hepatocellular carcinoma treatment efficacy criterion. OR (CR+PR) for all patients will be calculated.