A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice

A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma (HCC) in Routine Clinical Practice

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05200221

Enrollment

300

Registered

2022-01-20

Start date

2022-01-19

Completion date

2024-03-30

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Donafenib, Hepatocellular Carcinoma

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age ≥ 18 years old; 2. Histologically confirmed HCC or meet the clinical diagnostic criteria of HCC; 3. Unresectable HCC; 4. The doctor decided to use donafenib before the patient was enrolled in the study； 5. Informed consent and willing to complete the study according to the protocol.

Exclusion criteria

1. Those who are participating in clinical trials of other antitumor drugs; 2. Allergic to any component of Donafenib tablets; 3. Patients with active bleeding, active peptic ulcer, drug uncontrollable hypertension or severe liver dysfunction; 4. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events and serious adverse events.	an average of 1.5 year.	Incidence of adverse events and serious adverse events.

Secondary

Measure	Time frame	Description
Objective response rate (ORR)	an average of 1 year.	According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with complete response(CR) and partial response(PR) in the total number of patients.
Duration of remission (DoR)	an average of 1 year.	Time from the date of first confirmed CR or PR to the occurrence of disease progression.
Disease control rate (DCR)	an average of 1 year	According to RECIST v1.1 and mRECIST to evaluate the proportion of patients with CR, PR and stable disease(SD) in the total number of patients.
Progression-free survival(PFS)	an average of 1 year	PFS refers to the time from the date of enrollment to tumor progression or death from any cause.
overall survival(OS)	an average of 1 year	The time from the date of enrollment to the date of death from any cause.

Countries

China

Contacts

Primary ContactZheng Wang, M.D., Ph.D.

wzdoc@163.com13817390051

Outcome results