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

NCT ID: NCT00692770

Last Updated: 2018-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-15
• Study Completion Date: 2014-11-28

Brief 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).

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sorafenib (Nexavar, BAY43-9006)

Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)

Group Type: EXPERIMENTAL

Nexavar (Sorafenib, BAY43-9006)

Intervention Type: DRUG

Sorafenib 400 mg twice daily (BID)

Placebo

Participants received 2 tablets of placebo orally twice daily (BID)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 2 tablets twice daily (BID)

Interventions

Nexavar (Sorafenib, BAY43-9006)

Sorafenib 400 mg twice daily (BID)

Intervention Type: DRUG

Placebo

Placebo 2 tablets twice daily (BID)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• 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)
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Birmingham, Alabama, United States

Phoenix, Arizona, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Washington D.C., District of Columbia, United States

Miami, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Louisville, Kentucky, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Burlington, Massachusetts, United States

Ann Arbor, Michigan, United States

Minneapolis, Minnesota, United States

Minneapolis, Minnesota, United States

New York, New York, United States

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Providence Portland Medical Center

Portland, Oregon, United States

Portland, Oregon, United States

Pittsburgh, Pennsylvania, United States

Houston, Texas, United States

Richmond, Virginia, United States

Seattle, Washington, United States

Seattle, Washington, United States

Pilar, Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Rosario, Santa Fe Province, Argentina

Camperdown, New South Wales, Australia

Randwick, New South Wales, Australia

Brisbane, Queensland, Australia

Heidelberg, Victoria, Australia

Melbourne, Victoria, Australia

Innsbruck, , Austria

Linz, , Austria

Vienna, , Austria

Bruxelles - Brussel, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

São Paulo, São Paulo, Brazil

São Paulo, , Brazil

Plovdiv, , Bulgaria

Varna, , Bulgaria

Calgary, Alberta, Canada

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Reñaca, Región de Valparaíso, Chile

Santiago, Santiago Metropolitan, Chile

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Nanning, Guangxi, China

Wuhan, Hubei, China

Changsha, Hunan, China

Changsha, Hunan, China

Nanjing, Jiangsu, China

Xi’an, Shanxi, China

Xi’an, Shanxi, China

Xi’an, Shanxi, China

Chengdu, Sichuan, China

Chengdu, Sichuan, China

Beijing, , China

Beijing, , China

Beijing, , China

Beijing, , China

Beijng, , China

Chongqing, , China

Dalian, , China

Hefei, , China

Shanghai, , China

Shanghai, , China

Tianjin, , China

Angers, , France

Bondy, , France

Bordeaux, , France

Créteil, , France

Lille, , France

Lyon, , France

Marseille, , France

Nice, , France

Paris, , France

Paris, , France

Rennes, , France

Toulouse, , France

Vandœuvre-lès-Nancy, , France

Villejuif, , France

München, Bavaria, Germany

München, Bavaria, Germany

Regensburg, Bavaria, Germany

Göttingen, Lower Saxony, Germany

Hanover, Lower Saxony, Germany

Aachen, North Rhine-Westphalia, Germany

Cologne, North Rhine-Westphalia, Germany

Düsseldorf, North Rhine-Westphalia, Germany

Essen, North Rhine-Westphalia, Germany

Mainz, Rhineland-Palatinate, Germany

Homburg/Saar, Saarland, Germany

Halle, Saxony-Anhalt, Germany

Magdeburg, Saxony-Anhalt, Germany

Berlin, , Germany

Hamburg, , Germany

Athens / Greece, , Greece

Hong Kong, , Hong Kong

Kwun Tong, , Hong Kong

Shatin, , Hong Kong

Bari, Apulia, Italy

Benevento, Campania, Italy

Napoli, Campania, Italy

Napoli, Campania, Italy

Bologna, Emilia-Romagna, Italy

Modena, Emilia-Romagna, Italy

Rome, Lazio, Italy

Milan, Lombardy, Italy

Milan, Lombardy, Italy

Turin, Piedmont, Italy

Cagliari, Sardinia, Italy

Catania, Sicily, Italy

Palermo, Sicily, Italy

Padua, Veneto, Italy

Kashiwa-shi, Chiba, Japan

Kanazawa, Ishikawa-ken, Japan

Yokohama, Kanagawa, Japan

Osakasayama-shi, Osaka, Japan

Suita, Osaka, Japan

Bunkyo-ku, Tokyo, Japan

Chuo-ku, Tokyo, Japan

Itabashi-ku, Tokyo, Japan

Minato-ku, Tokyo, Japan

Shibuya-ku, Tokyo, Japan

Shinjuku-ku, Tokyo, Japan

Fukuoka, , Japan

Kumamoto, , Japan

Kyoto, , Japan

Okayama, , Japan

Osaka, , Japan

Tokushima, , Japan

México, D.F., Mexico City, Mexico

Monterrey, Nuevo León, Mexico

México, D.F., , Mexico

Auckland, , New Zealand

Coimbra, , Portugal

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Moscow, , Russia

Moscow, , Russia

Obninsk, , Russia

Saint Petersburg, , Russia

Singapore, , Singapore

Singapore, , Singapore

Goyang-si, Gyeonggido, South Korea

Goyang-si, Gyeonggido, South Korea

Seoul, Seoul Teugbyeolsi, South Korea

Busan, , South Korea

Daegu, , South Korea

Jeollabuk-do, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Sabadell, Barcelona, Spain

Cruces/Barakaldo, Bilbao, Spain

Barcelona, Catalonia, Spain

Majadahonda, Madrid, Spain

Oviedo, Principality of Asturias, Spain

Badajoz, , Spain

Barcelona, , Spain

Córdoba, , Spain

Madrid, , Spain

Madrid, , Spain

Valladolid, , Spain

Gothenburg, , Sweden

Stockholm, , Sweden

Bern, , Switzerland

Zurich, , Switzerland

Changhua, , Taiwan

Kaohsiung City, , Taiwan

Kaohsung, , Taiwan

Tainan City, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Southampton, Hampshire, United Kingdom

Birmingham, West Midlands, United Kingdom

Leeds, West Yorkshire, United Kingdom

London, , United Kingdom

London, , United Kingdom

Manchester, , United Kingdom

Newcastle upon Tyne, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Chile; China; France; Germany; Greece; Hong Kong; Italy; Japan; Mexico; New Zealand; Portugal; Romania; Russia; Singapore; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

References

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.

Reference Type: RESULT

PMID: 26361969 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30108162 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27887632 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22212936 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 19806596 (View on PubMed)

Related Links

http://www.clinicaltrialsregister.eu/

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Other Identifiers

2008-001087-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

12414

Identifier Type: -

Identifier Source: org_study_id