Trial Condition(s):

Carcinoma, Hepatocellular

A Randomized, Double-Blinded, Placebo-Controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Bayer Identifier:

11849

ClinicalTrials.gov Identifier:

NCT00492752

EudraCT Number:

Not Available

Study Completed

Trial Purpose

The purpose of the study is
- Find out if patients receiving Sorafenib will live longer
- Find out if Sorafenib has any effect on patient reported outcomes
- Find out if Sorafenib prevents the growth or shrinks liver tumors and / or their metastases
- Determine the pharmacokinetics (PK) in patients with liver cancer

Inclusion Criteria
- Ages eligible for study: 18 years and above, Genders eligible for study: both 
- Patients who have a life expectancy of at least 12 weeks 
- Patients with advanced Hepatocellular carcinoma (HCC) (unresectable, and/or metastatic) which has been histologically or cytologically documented 
- Patients must have at least one tumor lesion that meets both of the following criteria
(1) Accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumors (RECIST)
(2) Not been previously treated with local therapy 
- Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible. Previously treated lesions will not be selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan 
- Patients who have an Eastern Co-operative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Exclusion Criteria
- Previous or concurrent cancer that is distinct in primary site or histology from HCC, EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta [Noninvasive papillary carcinoma], Tis [Carcinoma in situ: "flat tumor"]&T1 [Tumor invades subepithelial connective tissue]). Any cancer curatively treated > 3 years prior to entry is permitted 
- History of cardiac disease 
- Active clinically serious infections 
- Known history of human immunodeficiency virus (HIV) infection 
- Known central nervous system (CNS) tumors including metastatic brain disease 
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Trial Summary

Enrollment Goal
226
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

Status
Completed
 
Locations

PLA 81 Hospital

Nanjing, China, 210003

Status
Completed
 
Locations

Southwest Hospital of 3rd Military Medical University.

Chongqing, China, 400038

Status
Completed
 
Locations

Sir Run Run Shaw Hospital

Hangzhou, China, 310016

Status
Completed
 
Locations

Tongji Hosp. of Huazhong Univ. of Science & Technology

Wuhan, China, 430030

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 10016

Status
Completed
 
Locations

Chang-Guang Memorial Hospital

Taoyuan, Taiwan, China, 333

Status
Completed
 
Locations

Nanfang Hospital.

Guangzhou, China, 510515

Status
Completed
 
Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Status
Completed
 
Locations

Affiliated Hospital of Academy of Military Medical Sciences,

Beijing, China, 100039

Status
Completed
 
Locations

1st Affiliate Hosp., Dalian Med Univ.

Dalian, China, 116011

Status
Completed
 
Locations

2nd affiliate hospital of Dalian medical university.

Dalian, China, 116027

Status
Completed
 
Locations

Tianjin Medical University Cancer Hospital

Tianjin, China

Status
Completed
 
Locations

Cancer Hospital of Jiangsu Province

Nanjing, China, 210009

Status
Completed
 
Locations

Shanghai Changzheng Hospital

Shanghai, China, 200003

Status
Completed
 
Locations

Zhongshan Hospital Fudan University

Shanghai, China, 200032

Status
Completed
 
Locations

1st Affiliate Hospital of Anhui Medical University

Hefei , China, 230022

Status
Completed
 
Locations

Korea University Guro Hospital

Seoul, South Korea, 152-703

Status
Completed
 
Locations

Kyungpook National University Hospital

Daegu, South Korea, 702-701

Status
Completed
 
Locations

Veterans General Hospital

Taipei, Taiwan, China, 251

Status
Completed
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 500

Status
Completed
 
Locations

Chi-Mei Medical Center, Liouyine

Tainan, Taiwan, China, 736

Status
Completed
 

Trial Design