臨床研究等提出・公開システム

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

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

9

Age(y) Median : 74 (60-83) Sex Male/Female : 7/2 Maximum Tumor Diameter mm (Range) : Median 40 (19-129) Number of Tumors (Range) : Median 5 (1-20over) Performance Status : all cases 0 Etiology : HBV/HCV/Alcohol/MASH/Other 1/2/1/3/2 Child pugh 5/6 8/1

Informed consent obtained 10 Ineligible patient 1 Eligible patients 9

Right phrenic nerve paralysis 1 (Recovery after 6 months) Necrotizing cholecystitis 1 (Recovery after surgery)

Main endpoint: Tumor shrinkage after 8 weeks based on mRECIST : CR/PR/SD/PD 5/1/1/2, ORR (CR+PR) 66.7%, (95% CI: 29.9-92.5%) Secondary endpoints: Tumor shrinkage after 8 weeks based on RECICL CR/PR/SD/PD 5/1/2/1, ORR (CR+PR) 66.7%, (95% CI: 29.9-92.5% Six-months survival survey: All 9 patients survived Liver function after treatment: Before treatment: ALBI 1/2a/2b/3 3/4/1/1 Two-months after treatment: 3/3/2/1

Balloon-Occluded trans-arterial chemo-embolization with cisplatin and sparse gelatin slurry for hepatocellular carcinoma refractory or intolerant to atezolizumab and bevacizumab combination therapy had a favorable response rate of 66.7%. No severe deterioration in liver function was observed after treatment. One case of phrenic nerve paralysis and one case of necrotizing cholecystitis were observed as side effects, but both were improved, and all patients were confirmed to be alive six months later.

Dec. 01, 2025

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs031210114

Hasegawa Naoyuki

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba, Ibaraki

naoyuki-hasegawa@md.tsukuba.ac.jp

Hasegawa Naoyuki

University of Tsukuba

2-1-1, Amakubo, Tsukuba, Ibaraki

+81-29-853-3218

naoyuki-hasegawa@md.tsukuba.ac.jp

Complete

May. 26, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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)

Both

Hepatocellular Carcinoma

RAIB-TACE with in four weeks after Atezolizumab plus Bevacizumab

Hepatocellular Carcinoma, atezolizumab, bevacizumab, TACE

D006528

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.

(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

+81-29-853-3914

Mar. 23, 2021

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