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

Conditions
Hepatocellular Carcinoma
Interventions
Other: nonintervention
Registration Number
NCT05024539
Lead Sponsor
Shujun Yang
Brief Summary

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

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
300
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
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Regorafenib groupnoninterventionPatients were given only regorafenib orally
Joint groupnoninterventionThe patient was treated with regorafenib orally and in combination with other medications
Primary Outcome Measures
NameTimeMethod
The difference of overall survival in patients receiving different doses of regorafenib2021.11-2021.12

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.

The difference in overall survival between the two groups calculated by Kaplan-Meier2021.7-2021.12

Survival differences between the monotherapy and combination groups

Regorafenib in combination with other drugs2021.7-2021.10

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.

Secondary Outcome Measures
NameTimeMethod
Survival differences among the patients with different clinical phenotypes and genotypes2021.7-2021.10

To compare the survival of patients with Hepatocellular Carcinoma by gender, age, tumor site and other genotypes

Trial Locations

Locations (1)

Henan cancer hosiptal

🇨🇳

Zhengzhou, Henan, China

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