DonafenibPhase 2NCT05262959
A Single Center Study of Donafenib Combined With PD-1 + TACE in the First-line Treatment of aHCC
A Phase 2 study testing Donafenib, PD-1 and TACE in people with Donafenib, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Donafenib
- What is being tested?
- Donafenib, PD-1 and TACE
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 30 May 2024
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily enter the study and sign informed consent form (ICF);
- Age ≥ 18 years and ≤ 75 years, 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);
- ECOG : 0 ~ 1 ;
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- The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm;
- Previous TACE treatment ≤ 1 time;
- Life expectancy ≥ 3 months;
- For patients with HBV infection, if HBV-DNA is≥10^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to <10^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels;
- Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment:
- Blood routine examination criteria must be met: (no blood transfusion within 14 days)
- HB≥90g/L；
- ANC≥1.5×10^9/L；
- PLT≥70×10^9/L.
- Biochemical tests are subject to the following criteria:
- BIL <1.25xULN ；
- ALT and AST<5xULN；
- Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance>50ml/min ( Cockcroft-Gault formula)；
- Albumin≥28g/L；
- Electrolytes (phosphorus, calcium, magnesium, potassium) ≥ LLN;
- Urine protein <2+ or 24-hour urine protein quantitative detection ≤1.0 g/L.
- Blood coagulation indexes are subject to the following criteria:
- Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;
- Activated partial thromboplastin time（APTT）≤1.5 × ULN.
- The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment.
Who cannot join
- Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma;
- The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis;
- Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation;
- History of malignancy other than HCC within 5 years;
- Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment;
- Presence of uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion;
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- Patients who received liver transplant surgery, prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or palliative local treatment ≥2 times for HCC；
- History of organ and cell transplantation；
- TACE contraindications identified by the investigator;
- Active severe infection;
- Autoimmune disease or immune deficiency;
- Severe organ (heart, kidney) dysfunction;
- 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
Zhongshan Hospital, Fudan University,
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single Center Study of Donafenib Combined With Programmed Cell Death-1 （PD-1） + Transarterial Chemoembolization (TACE) in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC)
This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donafenib, PD-1Drug
Eligible subjects will receive Donafenib combined with PD-1 and TACE. Donafenib will be taken orally twice a day, 0.1mg each time.PD-1 will be used intravenously every 3 weeks.
TACEProcedure or surgery
TACE will be performed by the investigator based on the patient's tumor status.
| Study group | Role | What they receive |
|---|---|---|
| Donafenib | Experimental | Donafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib. Receives: Drug: Donafenib, PD-1; Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival 1(PFS 1)
PFS 1 refers to the time from the date of enrollment to the first documented tumor progression as assessed by mRECIST criteria or death from any cause.
Measured: an average of 1 year
Secondary outcomes (4)
Objective response rate (ORR) per mRECIST
The proportion of patients exhibiting a complete response or partial response to treatment, as assessed by mRECIST.
Measured: an average of 1 year
Disease control rate (DCR) per mRECIST
The proportion of patients exhibiting a complete response, partial response or stable disease, as assessed by mRECIST.
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 1.5 year
Adverse events and serious adverse events.
Incidence of adverse events and serious adverse events.
Measured: an average of 1.5 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Dec 2021
- Primary completion30 Apr 2024
- Study completion30 May 2024
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
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.Zhiping Yan, M.D., Ph.D., Principal investigator, Zhongshan Hospital, Fudan University, Shanghai, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262959
- Sponsor's protocol ID
- B2021-631R
- Status last verified
- Aug 2024
- First submitted
- 20 Feb 2022
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study of Donafenib Combined With Programmed Cell Death-1 （PD-1） + Transarterial Chemoembolization (TACE) in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC)
- ClinicalTrials.gov ID
- NCT05262959
- Acronym / sponsor ID
- B2021-631R
- Conditions
- Donafenib
- Keywords
- Donafenib, Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 2 Mar 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 expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Donafenib | Experimental | Drug: Donafenib, PD-1, Procedure: TACEDonafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Patients voluntarily enter the study and sign informed consent form (ICF);
- Age ≥ 18 years and ≤ 75 years, 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 (14 listed)
- Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma;
- The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis;
- Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation;
- History of malignancy other than HCC within 5 years;
- Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment;
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, PD-1Eligible subjects will receive Donafenib combined with PD-1 and TACE. Donafenib will be taken orally twice a day, 0.1mg each time.PD-1 will be used intravenously every 3 weeks. | Drug | Donafenib |
| TACETACE will be performed by the investigator based on the patient's tumor status. | Procedure or surgery | Donafenib |
Primary outcome
Progression-free survival 1(PFS 1)
Time frame: an average of 1 year
PFS 1 refers to the time from the date of enrollment to the first documented tumor progression as assessed by mRECIST criteria or death from any cause.
4 secondary outcomes
Objective response rate (ORR) per mRECIST
Time frame: an average of 1 year
Disease control rate (DCR) per mRECIST
Time frame: an average of 1 year
Overall survival (OS)
Time frame: an average of 1.5 year
Adverse events and serious adverse events.
Time frame: an average of 1.5 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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.
Zhiping Yan, 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?
A Phase 2 study testing Donafenib, PD-1 and TACE in people with 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 26 inclusion and 14 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: finished, as of the sponsor's last update on 13 Aug 2024. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival 1(PFS 1) (time frame: an average of 1 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 13 Aug 2024.