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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UNKNOWN
800 participants
OBSERVATIONAL
2023-01-05
2023-12-31
Brief Summary
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Detailed Description
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2. Study Design This is a multicenter, retrospective, real-world study that will collect data from patients treated with regorafenib at medical centers in China.
3. Data Collection 3.1 Screening Period
The study procedures to be performed at screening include:
1. . Determine eligible subjects according to the inclusion/exclusion criteria and document the results.
2. . Collect demographic characteristics (eg, age, sex, weight, BMI, and ECOG score);
3. . Collect past medical history;
4. . Collect primary tumor site;
5. . Collect information on prior treatments: all treatments received since diagnosis of advanced HCC, including each treatment regimen (including first-line therapy), start and end date, duration, best response;
6. . Collect information on liver function and ECOG score prior to the first dose of regorafenib;
7. . Collect results of laboratory tests performed prior to and after the first dose of regorafenib, including haematology, biochemistry and genetic testing (if any);
8. . Collect imaging data: the last imaging procedure performed prior to the first dose of regorafenib, such as CT, PET-CT, MRI, and whole-body bone scan (with at least 1 measurable lesion); and information related to metastases (such as metastases to lymph node, bone and/or lung).
3.2 Data Review Period of Regorafenib Treatment
The following information obtained during each cycle of regorafenib will be collected retrospectively:
1. . Liver function and ECOG score obtained prior to each dose (ie., the first day of each cycle) of regorafenib;
2. . Initial dose of regorafenib;
3. . Timing and method of dose adjustment, and adjusted doses;
4. . Final daily dose of regorafenib;
5. . Best response, time to best response, and number of treatment cycles;
6. . Imaging findings (including metastatic sites) related to response evaluation;
7. . Hematology laboratory tests (related to the underlying disease, tumor progression, and ADR);
8. . Any adverse reaction and corresponding CTCAE grade;
9. . Interrupted or discontinued treatment;
10. . The most recent laboratory tests (or alternative doctor's advice and tests) performed prior to the first day of each treatment cycle, including but not limit to hematology and biochemistry.
3.3 Progression and Survival Data Collection Period
The following information obtained during each cycle of regorafenib will be collected retrospectively:
1. . Time to progression
2. . Pattern of progression
3. . Subsequent treatment regimen, dose, number of cycles, efficacy;
4. . Survival status, time of death or last follow-up.
4\. Study Drug Generic name: Regorafenib Tablets Trade name: Stivarga® English name: Regorafenib Tablets
Dosage strength: 40 mg tablet Dosage form: Tablets Description: Oval tablets with pale-pink film coat Label dose and mode of administration: Recommended dosage is 160 mg, once daily for the first 21 days of each 28-day cycle. A minimum dose of 80 mg/day and a maximum dose of 160 mg/day are recommended.
Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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HCC participants who received the treatment of Regorafenib
HCC participants who received the treatment of Regorafenib
Regorafenib 40 MG
participants who received the treatment of Regorafenib
Interventions
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Regorafenib 40 MG
participants who received the treatment of Regorafenib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C;
3. Patients previously treated with regorafenib for at least one 28-day cycle after only one prior systemic therapy.
Exclusion Criteria
2. Patients with medical history of other malignant neoplasms.
18 Years
90 Years
ALL
No
Sponsors
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The Central Hospital of Lishui City
OTHER
Anhui Provincial Hospital
OTHER_GOV
Zhejiang University
OTHER
Sun Yat-sen University
OTHER
Wuxi People's Hospital
OTHER
Jiangsu Cancer Institute & Hospital
OTHER
ZhuHai Hospital
OTHER
Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
Professor
Central Contacts
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References
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Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24.
Zheng R, Qu C, Zhang S, Zeng H, Sun K, Gu X, Xia C, Yang Z, Li H, Wei W, Chen W, He J. Liver cancer incidence and mortality in China: Temporal trends and projections to 2030. Chin J Cancer Res. 2018 Dec;30(6):571-579. doi: 10.21147/j.issn.1000-9604.2018.06.01.
Zeng H, Chen W, Zheng R, Zhang S, Ji JS, Zou X, Xia C, Sun K, Yang Z, Li H, Wang N, Han R, Liu S, Li H, Mu H, He Y, Xu Y, Fu Z, Zhou Y, Jiang J, Yang Y, Chen J, Wei K, Fan D, Wang J, Fu F, Zhao D, Song G, Chen J, Jiang C, Zhou X, Gu X, Jin F, Li Q, Li Y, Wu T, Yan C, Dong J, Hua Z, Baade P, Bray F, Jemal A, Yu XQ, He J. Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries. Lancet Glob Health. 2018 May;6(5):e555-e567. doi: 10.1016/S2214-109X(18)30127-X.
Craig AJ, von Felden J, Garcia-Lezana T, Sarcognato S, Villanueva A. Tumour evolution in hepatocellular carcinoma. Nat Rev Gastroenterol Hepatol. 2020 Mar;17(3):139-152. doi: 10.1038/s41575-019-0229-4. Epub 2019 Dec 2.
Kudo M, Trevisani F, Abou-Alfa GK, Rimassa L. Hepatocellular Carcinoma: Therapeutic Guidelines and Medical Treatment. Liver Cancer. 2016 Nov;6(1):16-26. doi: 10.1159/000449343. Epub 2016 Nov 29.
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.
Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, Luo R, Feng J, Ye S, Yang TS, Xu J, Sun Y, Liang H, Liu J, Wang J, Tak WY, Pan H, Burock K, Zou J, Voliotis D, Guan Z. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. doi: 10.1016/S1470-2045(08)70285-7. Epub 2008 Dec 16.
Bruix J, Sherman M; American Association for the Study of Liver Diseases. Management of hepatocellular carcinoma: an update. Hepatology. 2011 Mar;53(3):1020-2. doi: 10.1002/hep.24199. No abstract available.
European Association for Study of Liver; European Organisation for Research and Treatment of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. Eur J Cancer. 2012 Mar;48(5):599-641. doi: 10.1016/j.ejca.2011.12.021. No abstract available.
Bruix J, Qin S, Merle P, Granito A, Huang YH, Bodoky G, Pracht M, Yokosuka O, Rosmorduc O, Breder V, Gerolami R, Masi G, Ross PJ, Song T, Bronowicki JP, Ollivier-Hourmand I, Kudo M, Cheng AL, Llovet JM, Finn RS, LeBerre MA, Baumhauer A, Meinhardt G, Han G; RESORCE Investigators. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017 Jan 7;389(10064):56-66. doi: 10.1016/S0140-6736(16)32453-9. Epub 2016 Dec 6.
Arai H, Battaglin F, Wang J, Lo JH, Soni S, Zhang W, Lenz HJ. Molecular insight of regorafenib treatment for colorectal cancer. Cancer Treat Rev. 2019 Dec;81:101912. doi: 10.1016/j.ctrv.2019.101912. Epub 2019 Oct 28.
Lee MJ, Chang SW, Kim JH, Lee YS, Cho SB, Seo YS, Yim HJ, Hwang SY, Lee HW, Chang Y, Jang JY. Real-world systemic sequential therapy with sorafenib and regorafenib for advanced hepatocellular carcinoma: a multicenter retrospective study in Korea. Invest New Drugs. 2021 Feb;39(1):260-268. doi: 10.1007/s10637-020-00977-4. Epub 2020 Aug 4.
Sung PS, Jang JW, Lee J, Lee SK, Lee HL, Yang H, Nam HC, Lee SW, Bae SH, Choi JY, Han NI, Yoon SK. Real-World Outcomes of Nivolumab in Patients With Unresectable Hepatocellular Carcinoma in an Endemic Area of Hepatitis B Virus Infection. Front Oncol. 2020 Jun 30;10:1043. doi: 10.3389/fonc.2020.01043. eCollection 2020.
Nair A, Reece K, Donoghue MB, Yuan WV, Rodriguez L, Keegan P, Pazdur R. FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma. Oncologist. 2021 Mar;26(3):e484-e491. doi: 10.1002/onco.13566. Epub 2020 Nov 10.
Related Links
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Other Identifiers
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V1.0 20220518
Identifier Type: -
Identifier Source: org_study_id