A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice
1 other identifier
observational
300
1 country
1
Brief Summary
This trial is a single center observational real-world study. It is planned to include 300 patients with unresectable hepatocellular carcinoma (uHCC) treated with Donafenib. The purpose of the study was to observe the effectiveness and safety of Donafenib in the real world.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2022
CompletedStudy Start
First participant enrolled
January 19, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedMarch 31, 2022
January 1, 2022
2 years
January 17, 2022
March 17, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events and serious adverse events.
Incidence of adverse events and serious adverse events.
an average of 1.5 year.
Secondary Outcomes (5)
Objective response rate (ORR)
an average of 1 year.
Duration of remission (DoR)
an average of 1 year.
Disease control rate (DCR)
an average of 1 year
Progression-free survival(PFS)
an average of 1 year
overall survival(OS)
an average of 1 year
Study Arms (1)
Donafenib
Patients with uHCC taking donafenib in clinical treatment
Eligibility Criteria
It is planned to include 300 patients with unresectable hepatocellular carcinoma treated with Donafenib.
You may qualify if:
- Age ≥ 18 years old;
- Histologically confirmed HCC or meet the clinical diagnostic criteria of HCC;
- Unresectable HCC;
- The doctor decided to use donafenib before the patient was enrolled in the study；
- Informed consent and willing to complete the study according to the protocol.
You may not qualify if:
- Those who are participating in clinical trials of other antitumor drugs;
- Allergic to any component of Donafenib tablets;
- Patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction;
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan Hospital, Fudan University,
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Zhou, M.D., Ph.D.
Zhongshan Hospital, Fudan University, Shanghai, China.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2022
First Posted
January 20, 2022
Study Start
January 19, 2022
Primary Completion
January 30, 2024
Study Completion
March 30, 2024
Last Updated
March 31, 2022
Record last verified: 2022-01