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

JRCT ID: jRCTs031210114

Registered date:26/05/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 27/06/2021
• Target sample size: 19
• Study type: Interventional
• Intervention(s): RAIB-TACE with in four weeks after Atezolizumab plus Bevacizumab

Outcome(s)

• Primary Outcome: 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.

Secondary Outcome

(1)Patient-based tumor reduction effect based on mRECIST by central judgment.
(2)Survival rate after 6 months
(3)The percentage of patients who remain A on the Child-Pugh score postoperatively.
(4)As a composite endpoint, evaluate the OR of patients who remain A on the Child-Pugh score post
operatively (i.e., those without hepatic decompensation).
(5)RAIB-TACE-induced changes in liver reserve (pre-treatment vs. 1 and 2 months after treatment)
- Changes in albumin, ALBI score and CP point, score in all patients
- Changes in albumin, ALBI score and CP point in patients treated in subarea 2-4
- Changes in albumin, ALBI score and CP point in patients treated in the 5-7 subarea
- Changes in albumin, ALBI score and CP point in patients treated with whole liver territory
- The frequency of grade exacerbation of blood data according to CTCAE criteria will be examined in terms of total bilirubin, albumin, AST, ALT, and PT INR at 1 and 2 months post treatment, respectively.
- Post-treatment transition rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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)

Related Information

• Primary Sponsor: Hasegawa Naoyuki
• Source(s) of Monetary Support: Tsukuba University hospital Mito community medicine education center research funding