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

NCT00692770 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 124142008-001087-36
• Study Type: interventional
• Target: 1,114
• Locations: 27 countries
• Sites: 194

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

Keywords

Hepatocellular carcinoma; Sorafenib; Adjuvant; Surgical resection; Ablation; Nexavar; Adjuvant therapy; Liver cancer; HCC; STORM

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Time to Recurrence (TTR) by Independent Assessment

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

• Overall Survival (OS)

  From randomization of the first subject until 4 years later.

Other Outcomes (7)

• Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Index Score

  Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit

• Patient Reported Outcomes: Euroqol-5 Dimensions (EQ-5D) - Visual Analogue Scale (VAS) Score

  Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit

• Patient Reported Outcomes: Functional Assessment of Cancer Therapy (FACT)- Hepatobiliary Subscale (HEP) Score

  Cycle (C) Day (D)1, C2D1, C3D1 and subsequent cycles up to C18, end of intervention visit

Study Arms (2)

Sorafenib (Nexavar, BAY43-9006)

EXPERIMENTAL

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

Drug: Nexavar (Sorafenib, BAY43-9006)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Nexavar (Sorafenib, BAY43-9006) DRUG

Sorafenib 400 mg twice daily (BID)

Sorafenib (Nexavar, BAY43-9006)

Placebo DRUG

Placebo 2 tablets twice daily (BID)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (199)

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Birmingham, Alabama, 35294-3300, United States

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Phoenix, Arizona, 85054, United States

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Los Angeles, California, 90033, United States

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Los Angeles, California, 90095-7077, United States

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San Francisco, California, 94115, United States

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Washington D.C., District of Columbia, 20007, United States

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Miami, Florida, 33136, United States

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Atlanta, Georgia, 30322, United States

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Indianapolis, Indiana, 46202, United States

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Louisville, Kentucky, 40202, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02215, United States

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Burlington, Massachusetts, 01805, United States

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Ann Arbor, Michigan, 48109, United States

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Minneapolis, Minnesota, 55407, United States

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Minneapolis, Minnesota, 55455, United States

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New York, New York, 10029, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44195, United States

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Columbus, Ohio, 43210, United States

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Providence Portland Medical Center

Portland, Oregon, 97213, United States

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Portland, Oregon, 97239, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Houston, Texas, 77030, United States

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Richmond, Virginia, 23249, United States

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Seattle, Washington, 98101, United States

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Seattle, Washington, 98109, United States

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Pilar, Buenos Aires, B1629ODT, Argentina

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Buenos Aires, Ciudad Auton. de Buenos Aires, C1181ACH, Argentina

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Rosario, Santa Fe Province, S2002KDS, Argentina

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Camperdown, New South Wales, 2050, Australia

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Randwick, New South Wales, 2031, Australia

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Brisbane, Queensland, 4120, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Innsbruck, 6020, Austria

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Linz, 4020, Austria

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Vienna, 1090, Austria

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Bruxelles - Brussel, 1200, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

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Porto Alegre, Rio Grande do Sul, 90470 340, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, São Paulo, 01323-001, Brazil

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São Paulo, 01246-903, Brazil

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Plovdiv, 4002, Bulgaria

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Varna, 2010, Bulgaria

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Calgary, Alberta, T2N 4N1, Canada

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Edmonton, Alberta, T6G 1Z2, Canada

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Vancouver, British Columbia, V5Z 4E6, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Reñaca, Región de Valparaíso, Chile

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Santiago, Santiago Metropolitan, 833-0024, Chile

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Guangzhou, Guangdong, 510060, China

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Guangzhou, Guangdong, 510080, China

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Guangzhou, Guangdong, 510515, China

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Nanning, Guangxi, 530021, China

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Wuhan, Hubei, 430022, China

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Changsha, Hunan, 410008, China

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Changsha, Hunan, 410013, China

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Nanjing, Jiangsu, 210002, China

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Xi’an, Shanxi, 710038, China

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Xi’an, Shanxi, 710061, China

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Xi’an, Shanxi, 710068, China

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Chengdu, Sichuan, 610041, China

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Chengdu, Sichuan, 610072, China

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Beijing, 100021, China

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Beijing, 100071, China

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Beijing, 100142, China

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Beijing, 100853, China

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Beijng, 100142, China

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Chongqing, 400038, China

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Dalian, 116027, China

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Hefei, 230022, China

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Shanghai, 200001, China

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Shanghai, 200438, China

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Tianjin, 300060, China

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Angers, 49933, France

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Bondy, 93143, France

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Bordeaux, 33000, France

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Créteil, 94010, France

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Lille, 59037, France

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Lyon, 69004, France

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Marseille, 13005, France

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Nice, 06202, France

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Paris, 75020, France

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Paris, 75571, France

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Rennes, 35000, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54500, France

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Villejuif, 94800, France

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München, Bavaria, 81377, Germany

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München, Bavaria, 81675, Germany

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Regensburg, Bavaria, 93042, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Hanover, Lower Saxony, 30625, Germany

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Aachen, North Rhine-Westphalia, 52074, Germany

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Cologne, North Rhine-Westphalia, 50937, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Essen, North Rhine-Westphalia, 45147, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Homburg/Saar, Saarland, 66421, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Berlin, 12200, Germany

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Hamburg, 20246, Germany

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Athens / Greece, 115 27, Greece

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Hong Kong, Hong Kong

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Kwun Tong, Hong Kong

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Shatin, Hong Kong

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Bari, Apulia, 70124, Italy

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Benevento, Campania, 82100, Italy

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Napoli, Campania, 80123, Italy

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Napoli, Campania, 80131, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Modena, Emilia-Romagna, 41124, Italy

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Rome, Lazio, 00168, Italy

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Milan, Lombardy, 20121, Italy

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Milan, Lombardy, 20133, Italy

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Turin, Piedmont, 10126, Italy

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Cagliari, Sardinia, 09134, Italy

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Catania, Sicily, 95122, Italy

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Palermo, Sicily, 90127, Italy

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Padua, Veneto, 35128, Italy

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Kashiwa-shi, Chiba, 277-8577, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Yokohama, Kanagawa, 232-0024, Japan

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Osakasayama-shi, Osaka, 589-8511, Japan

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Suita, Osaka, 565-0871, Japan

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Bunkyo-ku, Tokyo, 113-8655, Japan

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Chuo-ku, Tokyo, 104-0045, Japan

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Itabashi-ku, Tokyo, 173-8610, Japan

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Minato-ku, Tokyo, 105-8470, Japan

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Shibuya-ku, Tokyo, 150-8935, Japan

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Shinjuku-ku, Tokyo, 162-8666, Japan

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Fukuoka, 812-8582, Japan

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Kumamoto, 860-8556, Japan

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Kyoto, 606-8507, Japan

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Okayama, 700-8558, Japan

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Osaka, 537-8511, Japan

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Tokushima, 770-8503, Japan

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México, D.F., Mexico City, 14080, Mexico

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Monterrey, Nuevo León, 64710, Mexico

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México, D.F., 14050, Mexico

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Auckland, 1023, New Zealand

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Coimbra, 3000-075, Portugal

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Bucharest, 022326, Romania

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Cluj-Napoca, 400015, Romania

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Iași, 700106, Romania

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Moscow, 115478, Russia

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Moscow, 119991, Russia

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Obninsk, 249036, Russia

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Saint Petersburg, 197758, Russia

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Singapore, 119228, Singapore

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Singapore, 169608, Singapore

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Goyang-si, Gyeonggido, 410-769, South Korea

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Goyang-si, Gyeonggido, 411-706, South Korea

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Seoul, Seoul Teugbyeolsi, 135-720, South Korea

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Busan, 49241, South Korea

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Daegu, 700721, South Korea

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Jeollabuk-do, 561-712, South Korea

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Seoul, 05505, South Korea

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Seoul, 110-744, South Korea

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Seoul, 120-752, South Korea

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Seoul, 135-710, South Korea

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Sabadell, Barcelona, 08208, Spain

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Cruces/Barakaldo, Bilbao, 48903, Spain

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Barcelona, Catalonia, 08035, Spain

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Majadahonda, Madrid, 28222, Spain

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Oviedo, Principality of Asturias, 33011, Spain

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Badajoz, 06080, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Valladolid, 47012, Spain

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Gothenburg, 413 45, Sweden

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Stockholm, 141 86, Sweden

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Bern, 3010, Switzerland

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Zurich, 8091, Switzerland

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Changhua, 500-06, Taiwan

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Kaohsiung City, 807, Taiwan

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Kaohsung, 833, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Taoyuan District, 333, Taiwan

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Birmingham, West Midlands, B15 2TT, United Kingdom

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Leeds, West Yorkshire, LS9 7TF, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE5 9RS, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Related Publications (5)

• 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.

  PMID: 26361969 RESULT

• 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.

  PMID: 30108162 DERIVED

• 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.

  PMID: 27887632 DERIVED

• 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.

  PMID: 22212936 DERIVED

• 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.

  PMID: 19806596 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: BAYER

clinical-trials-contact@bayerhealthcare.com

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2008
• First Posted: June 6, 2008
• Study Start: August 15, 2008
• Primary Completion: November 29, 2013
• Study Completion: November 28, 2014
• Last Updated: August 8, 2018
• Results First Posted: December 1, 2014

Record last verified: 2018-07

Locations

FR (14); HK (3); CL (2); RO (3); SG (2); AU (3); KR (10); RU (4); BR (5); AR (3); US (29); CA (5); CN (24); IT (14); JP (17); NZ (1); ES (11); TW (7); BE (4); DE (15); GR (1); SE (2); GB (7); BU (2); ME (3); PT (1); CH (2)