A Real World Study of Regogfinib in HCC

December 28, 2022 updated by: Gao-jun Teng, Zhongda Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

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.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HCC participants who received the treatment of Regorafenib
Drug: Regorafenib 40 MG
participants who received the treatment of Regorafenib
Other Names:
  • Regorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 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.
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.
Time to progression (TTP)
Time Frame: 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
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)
Time Frame: Time from the start of regorafenib treatment to the date of the first documentation of objective response，assessed up to 60 months.
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)
Time Frame: 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.
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)
Time Frame: Time from the start of regorafenib treatment to the date of death or last follow up，whichever came first,assessed up to 60 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhongda Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 5, 2023

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 17, 2022

First Submitted That Met QC Criteria

September 26, 2022

First Posted (Actual)

September 28, 2022

Study Record Updates

Last Update Posted (Estimate)

December 29, 2022

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.0 20220518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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