Clinical trial NCT00494299: Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
Official title: Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
Cancer
Liver Cancer
TACE
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Aged of 18 and over
* Advanced hepatocellular carcinoma

Exclusion Criteria:

* History of prior systemic chemotherapy
* Failure in vital organ

Primary outcomes:
measure: Time to Progression (TTP)
timeFrame: From randomization of the first subject until radiological progression or recurrence whichever came first, assessed up to 39 months.
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From randomization of the first subject until 39 months later.
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Kashiwa
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Toon
country: Japan
state: Ehime
city: Iizuka
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Isesaki
country: Japan
state: Gunma
city: Maebashi
country: Japan
state: Gunma
city: Kure
country: Japan
state: Hiroshima
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Akashi
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Kasama
country: Japan
state: Ibaraki
city: Kanazawa
country: Japan
state: Ishikawa
city: Isehara
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Matsumoto
country: Japan
state: Nagano
city: Omura
country: Japan
state: Nagasaki
city: Kawachinagano
country: Japan
state: Osaka
city: Moriguchi
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Izunokuni
country: Japan
state: Shizuoka
city: Sunto
country: Japan
state: Shizuoka
city: Shimotsuke
country: Japan
state: Tochigi
city: Chuo-ku
country: Japan
state: Tokyo
city: Itabashi-ku
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Nerima-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Yonago
country: Japan
state: Tottori
city: Shimonoseki
country: Japan
state: Yamaguchi
city: Ube
country: Japan
state: Yamaguchi
city: Chuo
country: Japan
state: Yamanashi
city: Chiba
country: Japan
city: Fukui
country: Japan
city: Fukuoka
country: Japan
city: Gifu
country: Japan
city: Hiroshima
country: Japan
city: Hiroshima
country: Japan
city: Hiroshima
country: Japan
city: Kagoshima
country: Japan
city: Kagoshima
country: Japan
city: Kagoshima
country: Japan
city: Kumamoto
country: Japan
city: Kumamoto
country: Japan
city: Kumamoto
country: Japan
city: Kyoto
country: Japan
city: Miyazaki
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Toyama
country: Japan
city: Yamagata
country: Japan
city: Seoul
country: Korea, Republic of
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007.