DonafenibNCT05200221
A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma in Routine Clinical Practice
An observational study of Donafenib and Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Donafenib, Hepatocellular Carcinoma
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 19 Jan 2022to 30 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It is planned to include 300 patients with unresectable hepatocellular carcinoma treated with Donafenib.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University,
Shanghai, Shanghai Municipality, 200032
Jian Zhou, M.D., Ph.D., 13801914007, Zhou.jian@zs-hospital.sh.cn
About this study
Official title: 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.
- Conditions
- Donafenib, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Donafenib | Patients with uHCC taking donafenib in clinical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and serious adverse events.
Incidence of adverse events and serious adverse events.
Measured: an average of 1.5 year.
Secondary outcomes (5)
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.
Measured: an average of 1 year.
Duration of remission (DoR)
Time from the date of first confirmed CR or PR to the occurrence of disease progression.
Measured: an average of 1 year.
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.
Measured: an average of 1 year
Progression-free survival(PFS)
PFS refers to the time from the date of enrollment to tumor progression or death from any cause.
Measured: an average of 1 year
overall survival(OS)
The time from the date of enrollment to the date of death from any cause.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start19 Jan 2022
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DonafenibStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, M.D., Ph.D., Principal investigator, Zhongshan Hospital, Fudan University, Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200221
- Sponsor's protocol ID
- B2021-569R
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Real-world Study of Donafenib in the Treatment of Hepatocellular Carcinoma (HCC) in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT05200221
- Acronym / sponsor ID
- B2021-569R
- Conditions
- Donafenib, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib | – | –Patients with uHCC taking donafenib in clinical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include 300 patients with unresectable hepatocellular carcinoma treated with Donafenib.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse events and serious adverse events.
Time frame: an average of 1.5 year.
Incidence of adverse events and serious adverse events.
5 secondary outcomes
Objective response rate (ORR)
Time frame: an average of 1 year.
Duration of remission (DoR)
Time frame: an average of 1 year.
Disease control rate (DCR)
Time frame: an average of 1 year
Progression-free survival(PFS)
Time frame: an average of 1 year
overall survival(OS)
Time frame: an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Related trials for Donafenib
Not yet recruitingPhase 2
Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes
HCC - Hepatocellular Carcinoma, Diabetes
Not yet recruitingObservational study
The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus TACE or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
Donafenib Plus Sintilimab in Combination With TACE in Patients With Unresectable Hepatocellular Carcinoma
Unresectable Hepatocellular Carcinoma
Not yet recruitingPhase 2
The DoHAICs Study Expansion Phase
HCC - Hepatocellular Carcinoma
Not yet recruitingPhase 2
FOLFOX-HAIC Combined With Donafenib and Pucotenlimab as First-Line Treatment for Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc), Hepatic Arterial Infusion Chemotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhou, M.D., Ph.D. principal investigator
Zhongshan Hospital, Fudan University, Shanghai, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Donafenib and Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zheng Wang, M.D., Ph.D. (13817390051, wzdoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and serious adverse events. (time frame: an average of 1.5 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.