臨床研究等提出・公開システム

Scientific Title	Randomized phase II study of preceding radiofrequency ablation to atezolizuma plus bevacizumab combination therapy for the patients with unresectable hepatocellular carcinoma
Public Title	preceding RFA to Atezo+Bev for HCC patients

Contact for Scientific Queries	Name	Yamashita Taro
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takaramachi, Kanazawa, Ishikawa
	Telephone	+81-76-265-2235
	E-mail	taroy62m@staff.kanazawa-u.ac.jp
Contact for Public Queries	Name	Terashima Takeshi
	Affiliation	Kanazawa University Hospital
	Address	13-1, Takaramachi, Kanazawa, Ishikawa
	Telephone	+81-76-265-2235
	E-mail	tera@m-kanazawa.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 15, 2020
Actual date of first enrollment		Jan. 18, 2021
Target sample size		66
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	clinically diagnosed as hepatocellular carcinoma; unsuitable for local therapy; previously treated by systemic therapy; Preserved liver function; 20 years or older; ECOG Performance status <=2; preservation of major organ function; written informed consent
	Exclusion Criteria	refractory ascites or pleural effusion; unsuitable for RFA, risky varices; double cancer; metastases to central nervous system; severe complication; pregnant or lactating women, or women of childbearing potential; mental disorder; patients who investigator regards as inappropriate for candidate
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		hepatocellular carcinoma
Intervention(s)		Radiofreuquency ablation, Atezolizumab and bevacizumab combination therapy
Health Condition(s) Keyword		hepatocellular carcinoma
Intervention(s) Keyword		RFA, Atezolizumab and bevacizumab
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Progression-free survival
Secondary Outcome(s)		Overall survival, Immunological response, Objective response rate, Tumor control rate, Subsequent therapy, Adverse events

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Review Board, Kanazawa University
Address	13-1 Takaramachi, Kanazawa, Ishikawa
Telephone	+81-76-265-2048
E-Mail	hpsangak@adm.kanazawa-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 03, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history