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Carcinoma, HepatocellularPhase 3STORMNCT00692770

Sorafenib as Adjuvant Treatment in the Prevention Of Recurrence of Hepatocellular Carcinoma (STORM)

A Phase 3 study testing Nexavar (Sorafenib, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 199 sites in 28 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

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation). 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?
Nexavar (Sorafenib, BAY43-9006)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,114 participants
Where
199 sitesin 28 countries
Study dates
15 Aug 2008to 28 Nov 2014
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

  • Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered during this time period.
  • At least 3 weeks (21 days) but no more than 7 weeks (49 days), from resection or last local ablation course, to CT/MRI scan date
  • Male or female subjects >/= 18 years of age
  • Confirmation of CR (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
  • For subjects undergoing surgical resection pathology proven complete removal of tumor.
  • Intermediate or High Risk of recurrence as assessed by tumor characteristics.
Show all 9Show fewer
  • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
  • ECOG Performance Status of 0.
  • Adequate bone marrow, liver and renal function

Who cannot join

  • Recurrent HCC
  • Child-Pugh score 7 points with presence of ascites.
  • Low risk of recurrence after curative treatment
  • History of cardiovascular disease
  • History of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE version 3.0)
Show all 18Show fewer
  • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
  • Subjects with evidence or history of bleeding diathesis
  • Subjects undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated > 3 years prior to study entry as defined by the signing of informed consent..
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy
  • History of GI bleeding within 30 days of randomization.
  • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
  • Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
  • Liver transplantation, this includes patients on a transplant list with the intention to transplant

Trial locations and contacts

199 sites in 28 countries.

199 sites in 28 countries

United States29 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Birmingham, Alabama, 35294-3300

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Burlington, Massachusetts, 01805

  • Study site

    Cleveland, Ohio, 44106

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Los Angeles, California, 90033

  • Study site

    Los Angeles, California, 90095-7077

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Miami, Florida, 33136

  • Study site

    Minneapolis, Minnesota, 55407

  • Study site

    Minneapolis, Minnesota, 55455

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10029

  • Study site

    Phoenix, Arizona, 85054

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Study site

    Portland, Oregon, 97239

  • Study site

    Richmond, Virginia, 23249

  • Study site

    San Francisco, California, 94115

  • Study site

    Seattle, Washington, 98101

  • Study site

    Seattle, Washington, 98109

  • Study site

    Washington D.C., District of Columbia, 20007

Other trials in United States

China24 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Beijing, 100142

  • Study site

    Beijing, 100853

  • Study site

    Beijng, 100142

  • Study site

    Changsha, Hunan, 410008

  • Study site

    Changsha, Hunan, 410013

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Chengdu, Sichuan, 610072

  • Study site

    Chongqing, 400038

  • Study site

    Dalian, 116027

  • Study site

    Guangzhou, Guangdong, 510060

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Guangzhou, Guangdong, 510515

  • Study site

    Hefei, 230022

  • Study site

    Nanjing, Jiangsu, 210002

  • Study site

    Nanning, Guangxi, 530021

  • Study site

    Shanghai, 200001

  • Study site

    Shanghai, 200438

  • Study site

    Tianjin, 300060

  • Study site

    Wuhan, Hubei, 430022

  • Study site

    Xi’an, Shanxi, 710038

  • Study site

    Xi’an, Shanxi, 710061

  • Study site

    Xi’an, Shanxi, 710068

Other trials in China

Japan17 sites

  • Study site

    Bunkyo-ku, Tokyo, 113-8655

  • Study site

    Chuo-ku, Tokyo, 104-0045

  • Study site

    Fukuoka, 812-8582

  • Study site

    Kanazawa, Ishikawa-ken, 920-8641

  • Study site

    Kashiwa-shi, Chiba, 277-8577

  • Study site

    Kumamoto, 860-8556

  • Study site

    Kyoto, 606-8507

  • Study site

    Minato-ku, Tokyo, 105-8470

  • Study site

    Okayama, 700-8558

  • Study site

    Osaka, 537-8511

  • Study site

    Osakasayama-shi, Osaka, 589-8511

  • Study site

    Shibuya-ku, Tokyo, 150-8935

  • Study site

    Shinjuku-ku, Tokyo, 162-8666

  • Study site

    Suita, Osaka, 565-0871

  • Study site

    tabashi City, Tokyo, 173-8610

  • Study site

    Tokushima, 770-8503

  • Study site

    Yokohama, Kanagawa, 232-0024

Other trials in Japan

Germany15 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Berlin, 12200

  • Study site

    Cologne, North Rhine-Westphalia, 50937

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Halle, Saxony-Anhalt, 06120

  • Study site

    Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Homburg/Saar, 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

Other trials in Germany

France14 sites

  • Study site

    Angers, 49933

  • Study site

    Bondy, 93143

  • Study site

    Bordeaux, 33000

  • Study site

    Créteil, 94010

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69004

  • Study site

    Marseille, 13005

  • Study site

    Nice, 06202

  • Study site

    Paris, 75020

  • Study site

    Paris, 75571

  • Study site

    Rennes, 35000

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54500

  • Study site

    Villejuif, 94800

Other trials in France

Italy14 sites

  • Study site

    Bari, Apulia, 70124

  • Study site

    Benevento, Campania, 82100

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Cagliari, Sardinia, 09134

  • Study site

    Catania, Sicily, 95122

  • Study site

    Milan, Lombardy, 20121

  • Study site

    Milan, Lombardy, 20133

  • Study site

    Modena, Emilia-Romagna, 41124

  • Study site

    Naples, Campania, 80123

  • Study site

    Naples, Campania, 80131

  • Study site

    Padova, Veneto, 35128

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Rome, Lazio, 00168

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

Spain11 sites

  • Study site

    Badajoz, 06080

  • Study site

    Barcelona, Catalonia, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Córdoba, 14004

  • Study site

    Cruces/Barakaldo, Bilbao, 48903

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28040

  • Study site

    Majadahonda, Madrid, 28222

  • Study site

    Oviedo, Principality of Asturias, 33011

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Valladolid, 47012

Other trials in Spain

South Korea10 sites

  • Study site

    Busan, 49241

  • Study site

    Daegu, 700721

  • Study site

    Goyang-si, Gyeonggido, 410-769

  • Study site

    Goyang-si, Gyeonggido, 411-706

  • Study site

    Jeollabuk-do, 561-712

  • Study site

    Seoul, Seoul Teugbyeolsi, 135-720

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 135-710

Other trials in South Korea

Taiwan7 sites

  • Study site

    Changhua, 500-06

  • Study site

    Kaohsiung City, 807

  • Study site

    Kaohsung, 833

  • Study site

    Tainan, 704

  • Study site

    Taipei, 100

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

United Kingdom7 sites

  • Study site

    Birmingham, West Midlands, B15 2TT

  • Study site

    Leeds, West Yorkshire, LS9 7TF

  • Study site

    London, NW3 2QG

  • Study site

    London, SE5 9RS

  • Study site

    Manchester, M20 4BX

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

Australia5 sites

  • Study site

    Brisbane, Queensland, 4120

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Randwick, New South Wales, 2031

Other trials in Australia

Brazil5 sites

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Study site

    Porto Alegre, Rio Grande do Sul, 90470 340

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    São Paulo, São Paulo, 01323-001

  • Study site

    São Paulo, 01246-903

Other trials in Brazil

Canada5 sites

  • Study site

    Calgary, Alberta, T2N 4N1

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Belgium4 sites

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Ghent, 9000

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

Other trials in Belgium

Russia4 sites

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 119991

  • Study site

    Obninsk, 249036

  • Study site

    Saint Petersburg, 197758

Other trials in Russia

Argentina3 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH

  • Study site

    Pilar, Buenos Aires, B1629ODT

  • Study site

    Rosario, Santa Fe Province, S2002KDS

Other trials in Argentina

Austria3 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4020

  • Study site

    Vienna, 1090

Other trials in Austria

Hong Kong3 sites

  • Study site

    Hong Kong

  • Study site

    Kwun Tong

  • Study site

    Shatin

Other trials in Hong Kong

Mexico3 sites

  • Study site

    México, D.F., Mexico City, 14080

  • Study site

    México, D.F., 14050

  • Study site

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Romania3 sites

  • Study site

    Bucharest, 022326

  • Study site

    Cluj-Napoca, 400015

  • Study site

    Iași, 700106

Other trials in Romania

Bulgaria2 sites

  • Study site

    Plovdiv, 4002

  • Study site

    Varna, 2010

Other trials in Bulgaria

Chile2 sites

  • Study site

    Reñaca, Valparaiso

  • Study site

    Santiago, Santiago Metropolitan, 833-0024

Other trials in Chile

Singapore2 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 169608

Other trials in Singapore

Sweden2 sites

  • Study site

    Gothenburg, 413 45

  • Study site

    Stockholm, 141 86

Other trials in Sweden

Switzerland2 sites

  • Study site

    Bern, 3010

  • Study site

    Zurich, 8091

Other trials in Switzerland

Greece1 site

  • Study site

    Athens / Greece, 115 27

Other trials in Greece

New Zealand1 site

  • Study site

    Auckland, 1023

Other trials in New Zealand

Portugal1 site

  • Study site

    Coimbra, 3000-075

Other trials in Portugal

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled Study of Sorafenib as Adjuvant Treatment for Hepatocellular Carcinoma After Surgical Resection or Local Ablation.

To evaluate efficacy and safety of sorafenib versus placebo in the adjuvant treatment of Hepatocellular Carcinoma (HCC) after potentially curative treatment (surgical resection or local ablation).

Being tested
Nexavar (Sorafenib, BAY43-9006), Placebo
Keywords
Hepatocellular carcinoma, Sorafenib, Adjuvant, Surgical resection, Ablation, Nexavar, Adjuvant therapy, Liver cancer, HCC, STORM
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

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

  • Nexavar (Sorafenib, BAY43-9006)Drug

    Sorafenib 400 mg twice daily (BID)

  • PlaceboDrug

    Placebo 2 tablets twice daily (BID)

Study groups in NCT00692770
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006)ExperimentalParticipants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
Receives: Drug: Nexavar (Sorafenib, BAY43-9006)
PlaceboPlacebo comparatorParticipants received 2 tablets of placebo orally twice daily (BID)
Receives: Drug: Placebo

What is being measured

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

  1. Recurrence Free Survival (RFS) by Independent Assessment

    Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.

    Measured: From randomization up to 4 years or until disease recurrence whichever came first

Secondary outcomes (2)

  1. Time to Recurrence (TTR) by Independent Assessment

    TTR was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment. For subjects who had not recurred at the time of analysis, TTR was censored at their last date of evaluable scan before withdrawal for any other reason than recurrence. "NA" in the reported data indicates values could not be estimated due to censored data.

    Measured: From randomization up to 4 years or until disease recurrence whichever came first

  2. Overall Survival (OS)

    OS was defined as the time from randomization to date of death due to any cause. OS for subjects alive at the time of analysis was censored at their last date of contact. "NA" in the reported data indicates values could not be estimated due to censored data.

    Measured: From randomization of the first subject until 4 years later.

Timeline

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

  1. First posted6 Jun 2008 (estimated)
  2. Study start15 Aug 2008
  3. Primary completion29 Nov 2013
  4. Study completion28 Nov 2014

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00692770
Sponsor's protocol ID
12414
Other IDs
2008-001087-36, 2008
Acronym
STORM
Status last verified
Jul 2018
First submitted
5 Jun 2008
Last updated
8 Aug 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

    PubMed 26361969

  • Pinyol R, Montal R, Bassaganyas L, Sia D, Takayama T, Chau GY, Mazzaferro V, Roayaie S, Lee HC, Kokudo N, Zhang Z, Torrecilla S, Moeini A, Rodriguez-Carunchio L, Gane E, Verslype C, Croitoru AE, Cillo U, de la Mata M, Lupo L, Strasser S, Park JW, Camps J, Sole M, Thung SN, Villanueva A, Pena C, Meinhardt G, Bruix J, Llovet JM. Molecular predictors of prevention of recurrence in HCC with sorafenib as adjuvant treatment and prognostic factors in the phase 3 STORM trial. Gut. 2019 Jun;68(6):1065-1075. doi: 10.1136/gutjnl-2018-316408. Epub 2018 Aug 14.

    PubMed 30108162

  • Bouattour M, Soubrane O, de Gramont A, Faivre S. Adjuvant therapies in advanced hepatocellular carcinoma: moving forward from the STORM. Trials. 2016 Nov 25;17(1):563. doi: 10.1186/s13063-016-1675-8.

    PubMed 27887632

  • Kudo M. Adjuvant therapy after curative treatment for hepatocellular carcinoma. Oncology. 2011;81 Suppl 1:50-5. doi: 10.1159/000333259. Epub 2011 Dec 22.

    PubMed 22212936

  • Printz C. Clinical trials of note. Sorafenib as adjuvant treatment in the prevention of disease recurrence in patients with hepatocellular carcinoma (HCC) (STORM). Cancer. 2009 Oct 15;115(20):4646. doi: 10.1002/cncr.24673. No abstract available.

    PubMed 19806596

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nexavar (Sorafenib, BAY43-9006) in people with Carcinoma, Hepatocellular, run by Bayer at 199 sites in 28 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 9 inclusion and 18 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States, China, Japan, Germany, France and 23 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 1 Dec 2014). 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?

Recurrence Free Survival (RFS) by Independent Assessment (time frame: From randomization up to 4 years or until disease recurrence whichever came first). 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 NCT00692770, which also lists 5 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 8 Aug 2018.

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