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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05200221
Other study ID # B2021-569R
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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