Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
871 participants
INTERVENTIONAL
2009-07-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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urea-based cream
Advanced HCC throughout China were treated with 10% urea-based cream 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for up to 12 weeks
urea-based cream
urea-based cream (10% urea; Eucerin) 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for a maximum of 12 weeks .
BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator.
best supportive care
BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator
No interventions assigned to this group
Interventions
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urea-based cream
urea-based cream (10% urea; Eucerin) 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for a maximum of 12 weeks .
BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patients with hepatocellular carcinoma must be willing to participate in this study and provide the investigators with written consents;
* The patients must be willing and able to complete the biweekly visits for the first 3 months;
* The patients must be willing and able to fill in the patient's efficacy questionnaires. If the patients cannot use pens or pencils, the patient's acquaintances or the clinical staffs will complete these questionnaires based on the answers provided by the patients
* The patients must discontinue all prior cancer treatment in at least 3 weeks before enrollment;
* The patient's life expectancy is ≥3 months
* The patients must provide written informed consents
Exclusion Criteria
* The patients received sorafenib therapy prior to enrollment
* The patients combined other treatment or used other biological therapy, chemotherapy, experimental treatment or radiotherapy
* The patient's sorafenib dosage exceeds 400mg, twice daily
ALL
No
Sponsors
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Chinese Anti-Cancer Association
OTHER
Responsible Party
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Principal Investigators
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Sheng-Long Ye, PHD
Role: PRINCIPAL_INVESTIGATOR
Zhongshan Hospital, Fudan University, Shanghai, China
Locations
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301 Military Hospital, Beijing, China
Beijing, Beijing Municipality, China
302 Military Hospital, Beijing, China
Beijing, Beijing Municipality, China
Union Hospital of Fujian Medical University, Fujian, China
Fuzhou, Fujian, China
Guangdong Provincial People's Hospital, Guangdong, China
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Sun Yat-sen University, Guangdong, China
Guangzhou, Guangdong, China
Heilongjiang Provincial Cancer Hospital, Heilongjiang, China
Haerbin, Heilongjiang, China
The 81 Hospital of the Chinese People's Liberation Army, Nanjing, China
Nanjing, Jiangsu, China
Jilin Provincial Tumor Hospital, Jilin, China
Changchun, Jilin, China
Zhongshan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, China
Eastern Hepatobiliary Surgery Hospital of the Second Military Medical University, Shanghai, China
Shanghai, Shanghai Municipality, China
Tianjin Cancer Hospital, Tianjin, China
Tianjin, Tianjin Municipality, China
Countries
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References
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Bosch FX, Ribes J, Cleries R, Diaz M. Epidemiology of hepatocellular carcinoma. Clin Liver Dis. 2005 May;9(2):191-211, v. doi: 10.1016/j.cld.2004.12.009.
Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, Liang DC, Shau WY, Chen DS. Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group. N Engl J Med. 1997 Jun 26;336(26):1855-9. doi: 10.1056/NEJM199706263362602.
Young JL Jr, Ries LG, Silverberg E, Horm JW, Miller RW. Cancer incidence, survival, and mortality for children younger than age 15 years. Cancer. 1986 Jul 15;58(2 Suppl):598-602. doi: 10.1002/1097-0142(19860715)58:2+3.0.co;2-c.
Other Identifiers
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1163
Identifier Type: -
Identifier Source: org_study_id