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| Name | Class |
|---|---|
| The Central Hospital of Lishui City | OTHER |
| Anhui Provincial Hospital | OTHER_GOV |
| Zhejiang University | OTHER |
| Sun Yat-sen University |
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This is a non-interventional observational study with the primary objective of assessing the efficacy of regorafenib in patients with immediate or advanced stage HCC.
The study procedures to be performed at screening include:
3.2 Data Review Period of Regorafenib Treatment
The following information obtained during each cycle of regorafenib will be collected retrospectively:
3.3 Progression and Survival Data Collection Period
The following information obtained during each cycle of regorafenib will be collected retrospectively:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC participants who received the treatment of Regorafenib | HCC participants who received the treatment of Regorafenib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib 40 MG | Drug | participants who received the treatment of Regorafenib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival was defined as the time from the start of regorafenib treatment to the date of death from any cause or last follow-up | Time from the start of regorafenib treatment to the date of death from any cause or last follow-up,whichever came first, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival was defined as the time from the start of regorafenib treatment to the date of the first documentation of disease progression or death from any cause. | Time from the start of regorafenib treatment to the date of the first documentation of disease progression or death from any cause,whichever came first, assessed up to 60 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with immediate or advanced stage HCC who have been treated with regorafenib from January 2018 to December 2021 following only one prior systemic therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Lu, MD | Contact | +8615850654644 | lujian43307131@126.com |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31248666 | Result | 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. | |
| 30700925 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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| OTHER |
| Wuxi People's Hospital | OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| ZhuHai Hospital | OTHER |
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| Time to progression (TTP) | Time to progression was defined as the time from the start of regorafenib treatment to the date of the first documentation of disease progression. | Time from the start of regorafenib treatment to the date of the first documentation of disease progression,whichever came first, assessed up to 60 months |
| Objective response rate (ORR) | Objective response rate was defined as the proportion of patients with CR or PR in the overall population | Time from the start of regorafenib treatment to the date of the first documentation of objective response,assessed up to 60 months. |
| Disease control rate (DCR) | Disease control rate was defined as the proportion of patients with CR or PR or stable disease (SD) in the overall population | Time from the start of regorafenib treatment to the date of the first documentation of CR or PR or stable,assessed up to 60 months. |
| Adverse events (AEs) | adverse events (AEs) (including type and grade according to CTCAE 5.0) | Time from the start of regorafenib treatment to the date of death or last follow up,whichever came first,assessed up to 60 months. |
| Result |
| 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. |
| 29653628 | Result | 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. |
| 31792430 | Result | 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. |
| 27995084 | Result | 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. |
| 18650514 | Result | 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. |
| 19095497 | Result | 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. |
| 21374666 | Result | 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. |
| 22424278 | Result | 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. |
| 27932229 | Result | 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. |
| 31715423 | Result | 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. |
| 32749658 | Result | 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. |
| 32695681 | Result | 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. |
| 33044793 | Result | 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. |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |