RAIB-TACE for the Patients with Hepatocellular Carcinoma beyond Up-to 7 Criteria

JRCT ID: jRCTs031200334

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatocellular Carcinoma
• Date of first enrollment: 03/03/2021
• Target sample size: 19
• Study type: Interventional
• Intervention(s): RAIB-TACE for hepatocellular carcinoma beyond up to 7 criteria

Outcome(s)

• Primary Outcome: Efficacy of RAIB-TACE: Patient-based tumor reduction effect based on RECICL, 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)The percentage of patients who remain A on the Child-Pugh score postoperatively.
(3)As a composite endpoint, evaluate the OR of patients who remain A on the Child-Pugh score postoperatively (i.e., those without hepatic decompensation).
(4) OR (CR+PR) based on RECICLE and mRECIST will be calculated for the following patients' lesions.
- Patients with a total of 7 or more nodules in both lobes of the liver.
(Patients with more than 7 nodules in one lobe only are not included.
- Patients with AFP >400 ng/mL
- Patients with multiple nodules, including nodules larger than 6 cm
- Nodules larger than 7 cm
(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

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. 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.

Exclude 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.
11) Severe allergy to iodine contrast medium or other drugs.
12) Pregnant or lactating patients.
13) Other patients who are deemed unsuitable as subjects by the investigator (or subspecialist).
14) Previous radiation therapy for hepatocellular carcinoma.

Related Information

• Primary Sponsor: Hoshiai Sodai
• Source(s) of Monetary Support: Japan society for the promotion of science