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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200221
• Other study ID #: B2021-569R
• Status: Recruiting
• Start date: January 19, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Zheng Wang, M.D., Ph.D.
• Phone: 13817390051
• Email: wzdoc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University,	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and serious adverse events.	Incidence of adverse events and serious adverse events.	an average of 1.5 year.
Secondary	Objective response rate (ORR)	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.	an average of 1 year.
Secondary	Duration of remission (DoR)	Time from the date of first confirmed CR or PR to the occurrence of disease progression.	an average of 1 year.
Secondary	Disease control rate (DCR)	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.	an average of 1 year
Secondary	Progression-free survival(PFS)	PFS refers to the time from the date of enrollment to tumor progression or death from any cause.	an average of 1 year
Secondary	overall survival(OS)	The time from the date of enrollment to the date of death from any cause.	an average of 1 year