Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma-A Retrospective Study

Real-World Effectiveness of Regorafenib in the Treatment of Patients With Hepatocellular Carcinoma

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Other: nonintervention

Detailed Description

To analyze the real-world usage pattern, effectiveness and factors associated with the effectiveness of regorafenib in the treatment of patients with Hepatocellular Carcinoma. This retrospective, observational study included clinicopathological and follow-up data of patients with Hepatocellular Carcinoma who were treated with regorafenib from June 2017 to September 2020. Patients with incomplete data were excluded. Overall survival (OS) stratified by combination therapy with programmed cell death ligand-1 (PD-L1) inhibitors, chemotherapy and regorafenib dose was calculated by Kaplan Meier method and log rank test. R software version 4.0 was used for the analysis.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Shujun Yang, bachelor; Phone Number: 13803869419; Email: nkyang@126.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Recruiting
      • Henan cancer hosiptal
      • Contact: Shujun Yang, bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically proven Hepatocellular Carcinoma whose disease progressed after two lines of antitumor therapy were treated with regorafenib alone or in combination.

Description

1. Inclusion Criteria:

   1. Must be a pathologically proven Hepatocellular Carcinoma
   2. Must have been treated with regorafenib
   3. Regorafenib must be used after two lines of standard antitumor therapy

2. Exclusion Criteria:

   1. Application is less than one course of treatment with regorafenib
   2. First - or second-line treatment with regorafenib
   3. Patients with multiple primary cancers

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Regorafenib group; Patients were given only regorafenib orally	Other: nonintervention
Joint group; The patient was treated with regorafenib orally and in combination with other medications	Other: nonintervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in overall survival between the two groups calculated by Kaplan-Meier	Survival differences between the monotherapy and combination groups	2021.7-2021.12
The difference of overall survival in patients receiving different doses of regorafenib	In the real world, regorafenib was used in different dosages: 40mg,80mg,120mg,160mg,respectively. The difference in overall survival time of patients with different dosage was compared.	2021.11-2021.12
Regorafenib in combination with other drugs	In the real world, regorafenib was used in combination with chemotherapy, immunotherapy or other drugs, and the frequency of occurrence of different conditions was analyzed.	2021.7-2021.10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival differences among the patients with different clinical phenotypes and genotypes	To compare the survival of patients with Hepatocellular Carcinoma by gender, age, tumor site and other genotypes	2021.7-2021.10

Collaborators and Investigators

• Sponsor: Shujun Yang
• Collaborators: Henan Cancer Hospital
• Investigators: Study Director: Shujun Yang, Henan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2021
• Primary Completion (Anticipated): November 21, 2022
• Study Completion (Anticipated): December 21, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; regorafenib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: YShujun2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Clinical data of the patients
• IPD Sharing Time Frame: At any time
• IPD Sharing Access Criteria: Research needs
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No