A Real World Study of Regogfinib in HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05557656
• Other study ID #: V1.0 20220518
• Status: Not yet recruiting
• Start date: January 5, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Zhongda Hospital
• Contact: Jian Lu, MD
• Phone: +8615850654644
• Email: lujian43307131[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Patients with pathologically or clinically confirmed HCC;

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:

1. Patients with incomplete information that would impact the assessment of primary endpoint;

2. Patients with medical history of other malignant neoplasms.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Regorafenib 40 MG
participants who received the treatment of Regorafenib

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Zhongda Hospital	Anhui Provincial Hospital, Jiangsu Cancer Institute & Hospital, Sun Yat-sen University, The Central Hospital of Lishui City, Wuxi People's Hospital, Zhejiang University, ZhuHai Hospital

References & Publications (14)

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 N — View Citation

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, B — View Citation

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 — View Citation

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 — View Citation

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, — View Citation

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.1000-9604.2018.0 — View Citation

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, Lia — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.

External Links

•   Related Info