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

March 17, 2022 updated by: Shanghai Zhongshan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zheng Wang, M.D., Ph.D.
  • Phone Number: 13817390051
  • Email: wzdoc@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

It is planned to include 300 patients with unresectable hepatocellular carcinoma treated with Donafenib.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Donafenib
Patients with uHCC taking donafenib in clinical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events and serious adverse events.
Time Frame: an average of 1.5 year.
Incidence of adverse events and serious adverse events.
an average of 1.5 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 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.
an average of 1 year.
Duration of remission (DoR)
Time Frame: an average of 1 year.
Time from the date of first confirmed CR or PR to the occurrence of disease progression.
an average of 1 year.
Disease control rate (DCR)
Time Frame: 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.
an average of 1 year
Progression-free survival(PFS)
Time Frame: an average of 1 year
PFS refers to the time from the date of enrollment to tumor progression or death from any cause.
an average of 1 year
overall survival(OS)
Time Frame: an average of 1 year
The time from the date of enrollment to the date of death from any cause.
an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Jian Zhou, M.D., Ph.D., Zhongshan Hospital, Fudan University, Shanghai, China.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Anticipated)

January 30, 2024

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

January 17, 2022

First Submitted That Met QC Criteria

January 17, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2021-569R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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