Hepatocellular CarcinomaNCT05205629
A Real-world Study of Donafenib Combined With TACE-based Treatment in Patients With Unresectable HCC
An observational study of Hepatocellular Carcinoma and Donafenib, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Donafenib
- What is being tested?
- Donafenib combined with TACE
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 30 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: Source of subjects: Unresectable HCC patients treated with Donafenib and TACE from Zhongshan Hospital Affiliated to Fudan University.
Who may be able to join
- Patients voluntarily entered the study and signed informed consent form (ICF);
- Age: Be at least 18 years old and and there is no limit on the gender;
- Clinically or histologically diagnosed as unresectable HCC;
- There is at least one measurable lesions that meet the mRECIST standard;
- Child-pugh classification A or B (score≤7);
- The maximum number of TACE procedures allowed before enrolment was 2. All of those patients who had a history of prior TACE achieved complete response by previous TACE, but recurred more than 6 months later at the study entry
- ECOG : 0 ~ 2 ;
- Before the patients were enrolled in the study, doctors had decided to treat them with donafenib in combination with TACE.
Who cannot join
- Donafenib forbidden population:
- Those who are allergic to any component of the medicine;
- Active bleeding;
- Active peptic ulcer;
- Hypertension not controlled by drugs;
- Those with severe liver insufficiency.
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- Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
- Patients with a clear past history of neurological or psychiatric disorders;
- The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
- Unable to follow the research protocol for treatment or scheduled follow-up;
- Any other researcher who thinks they cannot be included.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University
Shanghai
Minjie Yang, M.D., Ph.D., 13122806500, yang.minjie@zs-hospital.sh.cn
About this study
Official title: A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma
This study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.
- Conditions
- Hepatocellular Carcinoma, Donafenib
- Being tested
- Donafenib combined with TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib combined with TACEDrug
Also called Donafenib plus TACE
Donafenib(200mg bid po) combined with TACE
| Study group | Role | What they receive |
|---|---|---|
| Donafenib + TACE | Not described Receives: Drug: Donafenib combined with TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.
Measured: an expected average of 8 months
Secondary outcomes (6)
Objective response rate
evaluated by investigators with mRECIST
Measured: an expected average of 12 months
Disease control rate
evaluated by investigators with mRECIST
Measured: an expected average of 12 months
Time to untreatable progression
It is defined as the time when a tumor that cannot be treated by TACE progresses, deteriorates to Child-pugh C, or appears extrahepatic metastasis.
Measured: an expected average of 12 months
Overall survival
The time from enrollment to the death from any cause
Measured: an expected average of 18 months
The incidence of AEs and SAEs by NCI-CTCAE v5.0
Safety index
Measured: an expected average of 18 months
Conversion rate
Defined as the proportion of patients who can undergo radical surgical resection through conversion therapy.
Measured: an expected average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start30 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 Hepatocellular CarcinomaStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205629
- Sponsor's protocol ID
- B2021-640R
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 23 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study of Donafenib Combined With TACE as a Basis for the Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05205629
- Acronym / sponsor ID
- B2021-640R
- Conditions
- Hepatocellular Carcinoma, Donafenib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 25 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 study is a prospective, single-center, observational real-world study. It is planned to enroll 150 patients with unresectable hepatocellular carcinoma treated with Donafenib combined with TACE-based treatment, so as to observe and evaluate the efficacy and safety of Donafenib combined with TACE-based treatment in patients with unresectable HCC.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib + TACE | – | Drug: Donafenib combined with TACE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Source of subjects: Unresectable HCC patients treated with Donafenib and TACE from Zhongshan Hospital Affiliated to Fudan University.
Key inclusion criteria (8 listed)
- Patients voluntarily entered the study and signed informed consent form (ICF);
- Age: Be at least 18 years old and and there is no limit on the gender;
- Clinically or histologically diagnosed as unresectable HCC;
- There is at least one measurable lesions that meet the mRECIST standard;
- Child-pugh classification A or B (score≤7);
Key exclusion criteria (12 listed)
- Donafenib forbidden population:
- Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
- Patients with a clear past history of neurological or psychiatric disorders;
- The patient had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
- Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donafenib combined with TACEAlso: Donafenib plus TACEDonafenib(200mg bid po) combined with TACE | Drug | Donafenib + TACE |
Primary outcome
Progression Free Survival
Time frame: an expected average of 8 months
Defined as the time from the start of enrollment to the occurrence of disease progression that cannot be treated by TACE or death due to various reasons.
6 secondary outcomes
Objective response rate
Time frame: an expected average of 12 months
Disease control rate
Time frame: an expected average of 12 months
Time to untreatable progression
Time frame: an expected average of 12 months
Overall survival
Time frame: an expected average of 18 months
The incidence of AEs and SAEs by NCI-CTCAE v5.0
Time frame: an expected average of 18 months
Conversion rate
Time frame: an expected average of 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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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.
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 Hepatocellular Carcinoma and Donafenib, 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 8 inclusion and 12 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 23 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 Minjie Yang, M.D., Ph.D. (13122806500, yang.minjie@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: an expected average of 8 months). 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 23 Mar 2022.