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Carcinoma, HepatocellularPhase 3SHARPNCT00105443

A Phase III Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 178 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Sorafenib (Nexavar, BAY43-9006)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
602 participants
Where
178 sitesin 23 countries
Study dates
Mar 2005to Nov 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 histologically or cytologically documented Hepatocellular Carcinoma (HCC)
  • 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 RECIST (Response Evaluation Criteria in Solid Tumors) (2) Not previously treated with local therapy
  • Patients who have an ECOG (Eastern Cooperative Oncology Group) PS (Performance Status) of 0, 1, or 2

Who cannot join

  • 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
  • Renal failure requiring hemo- or peritoneal dialysis
  • History of cardiac disease
  • Active clinically serious infections
  • Known history of human immunodeficiency virus (HIV) infection
  • Known central nervous system tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry

Trial locations and contacts

178 sites in 23 countries.

178 sites in 23 countries

United States35 sites

  • Study site

    Ann Arbor, Michigan, 48109-0362

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Canton, Ohio, 44718

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Houston, Texas, 77030-1502

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Los Angeles, California, 90057

  • Study site

    Los Angeles, California, 90095-7077

  • Study site

    Manhasset, New York, 11030-3876

  • Study site

    Miami, Florida, 33136

  • Study site

    New Haven, Connecticut, 06510-8019

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10029

  • Study site

    New York, New York, 10032

  • Study site

    Omaha, Nebraska, 68198-2000

  • Study site

    Orange, California, 92668-3298

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Phoenix, Arizona, 85054-4502

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Richmond, Virginia, 23249

  • Study site

    San Francisco, California, 94121

  • Study site

    Seattle, Washington, 98104

  • Study site

    Seattle, Washington, 98195-6174

  • Study site

    St Louis, Missouri, 63104

  • Study site

    Stanford, California, 94305

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tucson, Arizona, 85724

Other trials in United States

Germany16 sites

  • Study site

    Berlin, State of Berlin, 12200

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    Halle, Saxony-Anhalt, 06120

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Magdeburg, Saxony-Anhalt, 39120

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    München, Bavaria, 81377

  • Study site

    München, Bavaria, 81675

  • Study site

    Regensburg, Bavaria, 93042

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Russia16 sites

  • Study site

    Kazan', 420012

  • Study site

    Kirov, 610002

  • Study site

    Krasnodar, 350040

  • Study site

    Moscow, 105 203

  • Study site

    Moscow, 105229

  • Study site

    Moscow, 111 020

  • Study site

    Moscow, 113 811

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 129 010

  • Study site

    Moscow, 129110

  • Study site

    Saint Petersburg, 188663

  • Study site

    Saint Petersburg, 195 067

  • Study site

    Saint Petersburg, 197758

  • Study site

    Tolgliatti

  • Study site

    Yekaterinburg, 620036

  • Study site

    Yekaterinburg, 620102

Other trials in Russia

Spain12 sites

  • Study site

    Alicante, Alicante, 03010

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Córdoba, Córdoba, 14004

  • Study site

    Cruces/Barakaldo, Bilbao, 48903

  • Study site

    Madrid, Madrid, 28006

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Pamplona, Pamplona, 31008

  • Study site

    Valencia, Valencia, 46014

Other trials in Spain

Italy11 sites

  • Study site

    Avellino, 83100

  • Study site

    Bologna, 40138

  • Study site

    Forlì, Forlì, 47100

  • Study site

    Milan, 20122

  • Study site

    Milan, 20133

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90127

  • Study site

    Pavia, 27100

  • Study site

    Pisa, 56126

  • Study site

    Roma, 00144

  • Study site

    Rozzano, Milano, 20089

Other trials in Italy

France10 sites

  • Study site

    Bondy, 93143

  • Study site

    Bordeaux, 33000

  • Study site

    Clichy, 92110

  • Study site

    Dijon, 21000

  • Study site

    Lille, 59020

  • Study site

    Marseille, 13005

  • Study site

    Nantes, 44805

  • Study site

    Paris, 75020

  • Study site

    Rennes, 35062

  • Study site

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Argentina8 sites

  • Study site

    Bueno Aires, Ciudad Auton. de Buenos Aires, C1417DTB

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1120AAF

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1145ADP

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH

  • Study site

    Mar del Plata, Buenos Aires, 7600

  • Study site

    Pilar, Buenos Aires, B1629AHJ

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000GTB

  • Study site

    San Miguel de Tucumán, Tucumán Province, T4000HXU

Other trials in Argentina

Canada8 sites

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Edmonton, Alberta, T6G 2C8

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Ottawa, Ontario, K1H 1C4

  • Study site

    Toronto, Ontario, M5G 2N2

  • Study site

    Vancouver, British Columbia, V5Z 1H8

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Australia6 sites

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    East Bentleigh, Victoria, 3165

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Melbourne, Victoria, 3052

  • Study site

    Randwick, New South Wales, 2031

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Belgium6 sites

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

Other trials in Belgium

Greece6 sites

  • Study site

    Athens, 115 27

  • Study site

    Haidari, Attica, 12462

  • Study site

    Ioannina, 45500

  • Study site

    Thessaloniki, Thessaloniki, 54639

  • Study site

    Thessaloniki, Thessaloniki, 56403

  • Study site

    Thessaloniki, 540 07

Other trials in Greece

United Kingdom6 sites

  • Study site

    Bristol, Avon, BS2 8ED

  • Study site

    Glasgow, Stratchclyde, G11 6NT

  • Study site

    London, London, NW3 2QG

  • Study site

    London, London, SE1 9RT

  • Study site

    Newcastle upon Tyne, NE2 4HH

  • Study site

    Oxford, Oxfordshire, OX1 2JD

Other trials in United Kingdom

Brazil5 sites

  • Study site

    Belo Horizonte, 30180090

  • Study site

    Belo Horizonte, 30380490

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Porto Alegre, Rio Grande do Sul, 90619900

  • Study site

    São Paulo, São Paulo, 01246-903

Other trials in Brazil

Bulgaria5 sites

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1527

  • Study site

    Stara Zagora, 6000

  • Study site

    Varna, 9010

Other trials in Bulgaria

Israel4 sites

  • Study site

    Haifa, 84801

  • Study site

    Petah Tikva, Israel, 49100

  • Study site

    Tel Aviv, Israel, 64239

  • Study site

    Zrifin, Israel, 70300

Other trials in Israel

Mexico4 sites

  • Study site

    Mexico City, Mexico City, 14080

  • Study site

    México, D.F., 06720

  • Study site

    México, D.F., 14050

  • Study site

    Monterrey, 64000

Other trials in Mexico

Poland4 sites

  • Study site

    Gdansk, 80-952

  • Study site

    Poznan, 61-878

  • Study site

    Warsaw, 02-507

  • Study site

    Warsaw, 02-781

Other trials in Poland

Switzerland4 sites

  • Study site

    Bern, Canton of Bern, 3010

  • Study site

    Geneva, Canton of Geneva, 1211

  • Study site

    Sankt Gallen, Canton of St. Gallen, 9007

  • Study site

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Chile3 sites

  • Study site

    Santiago, Santiago Metropolitan, 833-0024

  • Study site

    Santiago

  • Study site

    Santiago Región Metropolitana

Other trials in Chile

Peru3 sites

  • Study site

    Comas Lima

  • Study site

    Lima, LIMA 34

  • Study site

    Lima Cercado, LIMA 1

Other trials in Peru

Romania3 sites

  • Study site

    Craiova Dolj, 200642

  • Study site

    Iași, Iaşi, 700111

  • Study site

    Timișoara, Timiș County, 300223

Other trials in Romania

New Zealand2 sites

  • Study site

    Auckland, 1023

  • Study site

    Wellington South, 6001

Other trials in New Zealand

Croatia1 site

  • Study site

    Zagreb, 10000

Other trials in Croatia

About this study

Official title: A Phase III Randomized, Placebo-controlled Study of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

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 of or shrinks liver tumors and/or their metastases. Determine the pharmacokinetics (PK) in patients with liver cancer.

Read the detailed description

The following abbreviations were used in the Adverse Event section:

  • international normalized ratio (inr)
  • Common Terminology Criteria for Adverse Events (ctcae)
  • Not Otherwise Specified (nos)
  • Gastrointestinal (gi)
  • Central nervous system (cns)
  • Absolute Neutrophil Count (anc)
  • Alanine aminotransferase (ALT)
  • Aspartate aminotransferase (AST)
  • Creatine phosphokinase (cpk)
  • Gammaglutamyltransferase (ggt)
  • Genitourinary (gu)
  • Atrioventricular (av)
Being tested
Sorafenib (Nexavar, BAY43-9006), Placebo
Keywords
Liver Cancer, Cancer
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment.

  • PlaceboDrug

    Sorafenib-matching placebo tablets were orally administered twice daily (bid).

Study groups in NCT00105443
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalSorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006)
PlaceboPlacebo comparatorSorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

    Measured: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment

  2. Time to Symptomatic Progression (TTSP)

    TTSP was defined as the time from randomization to the first documented symptomatic progression.

    Measured: from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment

Secondary outcomes (3)

  1. Time to Progression (TTP)

    TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.

    Measured: from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 19 months after start of enrollment

  2. Disease Control (DC)

    The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.

    Measured: time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

  3. Patients Reported Outcome (PRO) by Use of the FACT-Hep Questionnaire

    PRO is a disease-specific measure, developed as symptom-focused approach in HCC and measured by the response rates for the PWB and FWB subscales of the 45-item Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire. The FACT-Hep response rate was based on the number of subjects who achieved the 8-point minimally important difference (MID) for this subscale. FACT-Hep total score ranges from 0 to 180, where the highest score represents a maximum achievable quality of life (QoL) value.

    Measured: from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00105443
Sponsor's protocol ID
100554
Other IDs
2004-001773-26, 2004
Acronym
SHARP
Status last verified
Oct 2014
First submitted
14 Mar 2005
Last updated
31 Oct 2014
Data monitoring committee
Yes

Publications

  • Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

    PubMed 18650514

  • Wu W, Mao H, Song J, Yang F. Bibliometric analysis of hepatocellular carcinoma and tyrosine kinase inhibitors. Medicine (Baltimore). 2025 May 16;104(20):e42015. doi: 10.1097/MD.0000000000042015.

    PubMed 40388796

  • Bruix J, Cheng AL, Meinhardt G, Nakajima K, De Sanctis Y, Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: Analysis of two phase III studies. J Hepatol. 2017 Nov;67(5):999-1008. doi: 10.1016/j.jhep.2017.06.026. Epub 2017 Jul 4.

    PubMed 28687477

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 178 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in United States, Germany, Russia, Spain, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: from randomization to death due to any cause until an average 7.2 months later up to the data cut-off date approximately 19 months after start of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105443, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2014.

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