NCT05557656

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

September 17, 2022

Last Update Submit

December 28, 2022

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaRegorafenib

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Progression-free survival (PFS)

    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.

  • Time to progression (TTP)

    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)

    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)

    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)

    Time from the start of regorafenib treatment to the date of death or last follow up，whichever came first,assessed up to 60 months.

Study Arms (1)

HCC participants who received the treatment of Regorafenib

HCC participants who received the treatment of Regorafenib

Drug: Regorafenib 40 MG

Interventions

Regorafenib 40 MGDRUG

participants who received the treatment of Regorafenib

Also known as: Regorafenib
HCC participants who received the treatment of Regorafenib

Eligibility Criteria

Age18 Years - 90 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients with pathologically or clinically confirmed HCC;
  • Patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C;
  • Patients previously treated with regorafenib for at least one 28-day cycle after only one prior systemic therapy.

You may not qualify if:

  • Patients with incomplete information that would impact the assessment of primary endpoint;
  • Patients with medical history of other malignant neoplasms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 31248666RESULT

  • 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.

    PMID: 30700925RESULT

  • 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.

    PMID: 29653628RESULT

  • 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.

    PMID: 31792430RESULT

  • 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.

    PMID: 27995084RESULT

  • 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.

    PMID: 18650514RESULT

  • 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.

    PMID: 19095497RESULT

  • 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.

    PMID: 21374666RESULT

  • 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.

    PMID: 22424278RESULT

  • 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.

    PMID: 27932229RESULT

  • 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.

    PMID: 31715423RESULT

  • 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.

    PMID: 32749658RESULT

  • 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.

    PMID: 32695681RESULT

  • 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.

    PMID: 33044793RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

regorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Central Study Contacts

Jian Lu, MD

CONTACT

+8615850654644lujian43307131@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 28, 2022

Study Start

January 5, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

December 29, 2022

Record last verified: 2022-12