AzTrials
AzTrials

Hepatocellular CarcinomaNCT05557656

A Real World Study of Regogfinib in HCC

An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Regorafenib 40 MG
How many people
800 participants
Where
No sites listed yet
Study dates
5 Jan 2023to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Jian Lu, MD contact

+8615850654644

lujian43307131@126.com

About this study

Official title: A Real World Study of Regogfinib in the Treatment of Advanced Hepatocellular Carcinoma

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.

Read the detailed description
  1. Study Objectives Primary Objective: To assess the efficacy of regorafenib in patients with immediate or advanced stage HCC Secondary objective: To assess the safety of regorafenib in patients with immediate or advanced stage HCC
  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.
  5. 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.

Being tested
Regorafenib 40 MG
Keywords
Hepatocellular Carcinoma, Regorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regorafenib 40 MGDrug

    Also called Regorafenib

    participants who received the treatment of Regorafenib

Study groups in NCT05557656
Study groupRoleWhat they receive
HCC participants who received the treatment of RegorafenibHCC participants who received the treatment of Regorafenib
Receives: Drug: Regorafenib 40 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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

  3. Objective response rate (ORR)

    Objective response rate was defined as the proportion of patients with CR or PR in the overall population

    Measured: Time from the start of regorafenib treatment to the date of the first documentation of objective response，assessed up to 60 months.

  4. 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

    Measured: 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.

  5. Adverse events (AEs)

    adverse events (AEs) (including type and grade according to CTCAE 5.0)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2022
  2. Study start5 Jan 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05557656
Sponsor's protocol ID
V1.0 20220518
Status last verified
Dec 2022
First submitted
17 Sep 2022
Last updated
29 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31248666

  • 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.

    PubMed 30700925

  • 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.

    PubMed 29653628

  • 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.

    PubMed 31792430

  • 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.

    PubMed 27995084

  • 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.

    PubMed 18650514

  • 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.

    PubMed 19095497

  • 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.

    PubMed 21374666

  • 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.

    PubMed 22424278

  • 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.

    PubMed 27932229

  • 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.

    PubMed 31715423

  • 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.

    PubMed 32749658

  • 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.

    PubMed 32695681

  • 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.

    PubMed 33044793

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian Lu, MD (+8615850654644, lujian43307131@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05557656, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in