Study of HAIC added on chemotherapy in patients with with unresectable advanced Hepatocellular Carcinoma

JRCT ID: jRCTs061210065

Registered date:17/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable advanced Hepatocellular Carcinoma
• Date of first enrollment: 07/01/2022
• Target sample size: 67
• Study type: Interventional
• Intervention(s): Make a comparison between two groups of Unresectable advanced Hepatocellular Carcinoma. One group is given the chemotherapy with Atezolizumab plus Bevacizumab. Other is given the HAIC within 4 weeks after chemotherapy with Atezolizumab plus Bevacizumab.

Outcome(s)

• Primary Outcome: Response Rate(mRECIST)

Secondary Outcome

1 Response Rate(RECIST ver1.1)
2 Progression-Free Survival
3 Disease Control Rate
4 Overall Survival
5 Response Rate, Progression-Free Survival, Disease Control Rate, Overall Survival by past treatment
6 Transition rate to curative treatment
7 Adverse Event

Key inclusion & exclusion criteria

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

Include criteria

1 20 age old over
2 Regardless of gender
3 Less than 1 of performance status
4 Patients who diagnosed with unresectable advanced Hepatocellular Carcinoma
5 Patients who have no treatment history of HAIC with Cisplatin
6 Patients who are getting treatment with Atezolizumab plus Bevacizumab
7 Measurable tumors in the liver
8 Patienst who have been fully informed consent

Exclude criteria

1 Patients with Child-Pugh score of 8 points or more
2 Allergy for contrast media
3 Less than 30 mL/min of eGFR
4 Allergy for Cisplatin
5 Allergy for Atezolizumab
6 Allergy for Bevacizumab
7 History of Hemoptysis
8 History of autoimmune disease
9 Interstitial pneumonia
10 Intraperitoneal inflamation or wounded
11 Brain metastasis
12 Congenital hemorrhagic disease
13 Severe Hart failure
14 Being pregnant or possibly pregnant
15 Patients who judged as inappropriate candidate by the chief medical examine

Related Information

• Primary Sponsor: Takeuchi Yasuto
• Source(s) of Monetary Support: Nippon Kayaku Co.,Ltd.