HCCPhase 2/3NCT02645981
Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma
A Phase 2/3 study testing Donafenib and Sorafenib in people with HCC, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites in China.
Trial summary
Donafenib versus sorafenib for advanced hepatocellular cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- Donafenib and Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2016to 17 Dec 2019
- Phase
- Phase 2/3
- 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
Who may be able to join
- Above 18 years old;
- Patients with measurable, histologically or clinical proven, inoperable HCC;
- Patients wtih measurable lesion and proved by independent radiology committee(IRC);
- Child-Pugh (CP) score of 7 or less；
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
- Patients had not received prior systemic treatments for HCC;
Show all 10Show fewer
- Life expectancy at least 3 months;
- Adequate hepatic and renal function;
- Adequate hematologic function (platelet count,≥75×109per liter;hemoglobin ≥9.0g per deciliter;neutrophil≥1.5×109per liter,);
- Prothrombin time international normal.
Who cannot join
- Patients received operate in 3 months;
- Patients received transcatheter arterial chemoembolization（TACE） in 4 weeks;
- Patients had received systemic therapy;
- Patients had prior treatment with sorafenib;
- Central nervous system(CNS) involvement;
- Severe or mild-degree ascitic fluid;
- Main portal vein tumor thrombus;
- Inferior venae cava tumor thrombus.
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Hospital Sichuan University
Chengdu, Sichuan, 610042
The PLA 81 Hospital
Nanjing, Jiangsu, 025
About this study
Official title: Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
Donafenib versus sorafenib for advanced hepatocellular cancer.
Read the detailed description
This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafenibDrug
Also called CM4307
Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects
SorafenibDrug
Also called Nexavar
Control
| Study group | Role | What they receive |
|---|---|---|
| Donafenib | Experimental | Drug:Donafenib; Dose:200mg,bid,po. Receives: Drug: Donafenib |
| Sorafenib(Nexavar) | Active comparator | Drug:Sorafenib; Dose:400mg,bid,po. Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Patient visits are scheduled every 8 weeks to monitor efficacy.
Measured: 3 years
Secondary outcomes (2)
Progress Free Survival
Patient visits are scheduled every 8 weeks to monitor efficacy.Progressive disease is measured from the date of randomization until dead or disease progression according to Response Evaluation Criteria in Solid Tumors(Version 1.1)
Measured: 2 years
Percentage of adverse events
Patient visits are scheduled every 4 weeks to monitor safety and drug accountability. Patients were monitored for adverse events by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (NCICTCAE) version 4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startMar 2016
- Primary completion27 Nov 2019
- Study completion17 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Suzhou Zelgen Biopharmaceuticals Co.,LtdThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Shukui Qin, MD, Study chair, The PLA 81 HospitalFeng Bi, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645981
- Sponsor's protocol ID
- ZGDH3
- Status last verified
- Oct 2019
- First submitted
- 31 Dec 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bi F, Qin S, Gu S, Bai Y, Chen Z, Wang Z, Ying J, Lu Y, Meng Z, Pan H, Yang P, Zhang H, Chen X, Xu A, Cui C, Zhu B, Wu J, Xin X, Wang J, Shan J, Chen J, Zheng Z, Xu L, Wen X, You Z, Ren Z, Xu J, Du C, Fan Q, Zhang L, Tao M, Jiang D, Wang S, Chen Y, Sheng J, Zhuang X, Wu J. Analysis of common treatment-related adverse events of donafenib and its correlation with efficacy: exploratory analysis of the ZGDH3 study. Eur J Med Res. 2025 Oct 29;30(1):1040. doi: 10.1186/s40001-025-03297-6.
PubMed 41163129
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Donafenib in Patients With Advanced Hepatocellular Carcinoma: a Controlled,Multicentre,Randomised, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT02645981
- Acronym / sponsor ID
- ZGDH3
- Conditions
- HCC
- Keywords
- Donafeinb, Sorafenib, Phase 3, Overall Survival
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- Mar 2016
- Primary completion
- 27 Nov 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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.
Donafenib versus sorafenib for advanced hepatocellular cancer.
Detailed description
This phase 3 study of donafenib, an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases, is to assess efficacy and safety in patients wiht advanced hepatocellular carcinoma (HCC).The study is a randomised,controlled,multicentre study.The controlled drug is sorafenib(Nexavar).The primary endpoint is overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donafenib | Experimental | Drug: DonafenibDrug:Donafenib; Dose:200mg,bid,po. |
| Sorafenib(Nexavar) | Active comparator | Drug: SorafenibDrug:Sorafenib; Dose:400mg,bid,po. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Above 18 years old;
- Patients with measurable, histologically or clinical proven, inoperable HCC;
- Patients wtih measurable lesion and proved by independent radiology committee(IRC);
- Child-Pugh (CP) score of 7 or less；
- Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
Key exclusion criteria (8 listed)
- Patients received operate in 3 months;
- Patients received transcatheter arterial chemoembolization（TACE） in 4 weeks;
- Patients had received systemic therapy;
- Patients had prior treatment with sorafenib;
- Central nervous system(CNS) involvement;
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 |
|---|---|---|
| DonafenibAlso: CM4307Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects | Drug | Donafenib |
| SorafenibAlso: NexavarControl | Drug | Sorafenib(Nexavar) |
Primary outcome
Overall Survival
Time frame: 3 years
Patient visits are scheduled every 8 weeks to monitor efficacy.
2 secondary outcomes
Progress Free Survival
Time frame: 2 years
Percentage of adverse events
Time frame: 3 years
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 9 Jan 2020.
- Derived from this study: PubMed 41163129Bi F, Qin S, Gu S, Bai Y, Chen Z, Wang Z, Ying J, Lu Y, Meng Z, Pan H, Yang P, Zhang H, Chen X, Xu A, Cui C, Zhu B, Wu J, Xin X, Wang J, Shan J, Chen J, Zheng Z, Xu L, Wen X, You Z, Ren Z, Xu J, Du C, Fan Q, Zhang L, Tao M, Jiang D, Wang S, Chen Y, Sheng J, Zhuang X, Wu J. Analysis of common treatment-related adverse events of donafenib and its correlation with efficacy: exploratory analysis of the ZGDH3 study. Eur J Med Res. 2025 Oct 29;30(1):1040. doi: 10.1186/s40001-025-03297-6.
- Individual participant dataSharing planned: No
Related trials for HCC
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
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.
Shukui Qin, MD study chair
The PLA 81 Hospital
Feng Bi, MD study chair
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Donafenib and Sorafenib in people with HCC, run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd at 2 sites 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 10 inclusion and 8 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall Survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02645981, which also lists 1 linked publication.
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 9 Jan 2020.