臨床研究等提出・公開システム

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ON-DEMAND TACE COMBINED WITH ATEZOLIZUMAB PLUS BEVACIZUMAB (ATEZO/BEV) OR ON-DEMAND TACE ALONE IN PATIENTS WITH UNTREATED HEPATOCELLULAR CARCINOMA

A Study of TACE Combined With Atezolizumab Plus Bevacizumab or TACE Alone in Patients With Untreated Hepatocellular Carcinoma

Lidan Bai

F. Hoffmann-La Roche Ltd

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

clinical-trials@chugai-pharm.co.jp

Clinical trials information

Chugai Pharmaceutical Co., Ltd.

1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo

+81-120-189-706

clinical-trials@chugai-pharm.co.jp

Not Recruiting

Feb. 26, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- onfirmed diagnosis of HCC by histology/ cytology or clinical criteria
- Eligible for TACE treatment
- No prior systemic therapy for HCC, especially immunotherapy
- No prior locoregional therapy to the target lesion(s)
- At least one measurable untreated lesion
- ECOG Performance Status of 0-1
- Child-Pugh class A

Evidence of Vp3/4 and hepatic vein tumor thrombus (HVTT)
Evidence of extrahepatic spread (EHS)
Being a candidate for curative treatments
Any condition representing a contraindication to TACE as determined by the investigators
Active or history of autoimmune disease or immune deficiency
Untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk for bleeding
A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
Evidence of bleeding diathesis or significant coagulopathy

Both

Intermediate stage HCC

atezolizumab: 1200 mg by intravenous infusion on Day 1 of each 21-day cycle
bevacizumab: 15 mg/kg by intravenous infusion on Day 1 of each 21-day cycle

Efficacy
Observation/medical examination, RECICL

Safety, Efficacy
Observation/medical examination, RECICL

+81-82-257-5596

Jan. 12, 2021

Yes

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

China