Hepatocellular CarcinomaNCT06581315
Postoperative Adjuvant Therapy of Donafenib for Hepatocellular Carcinoma
A study testing Donafenib in people with Hepatocellular Carcinoma and Adjuvant Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Adjuvant Therapy
- What is being tested?
- Donafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2024to 30 Aug 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
- High Risk of recurrence as assessed by tumor characteristics
- Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
- Child-Pugh Class A statu
- ECOG Performance Status of 0 or 1
- CT/MR confirmed no recurrence or metastasis at ≥4 weeks after surgery
- Expected survival time of no less than 3 months
Who cannot join
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Evidence of residual or a history of spontaneous tumor rupture
- Recurrent HCC
- Prior received Liver transplantation
- Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
- AFP does not return to normal 4 weeks after operation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120
Changzhen Shang, MD, +86-20-3407 0701, shchzh2@mail.sysu.edu.cn
About this study
Official title: Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
This study aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.
- Conditions
- Hepatocellular Carcinoma, Adjuvant Therapy
- Being tested
- Donafenib
- Keywords
- Hepatocellular Carcinoma, Adjuvant Therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonafenibDrug
Also called Zepsun
Donafenib 100 mg twice daily (BID)
| Study group | Role | What they receive |
|---|---|---|
| Arm A (Donafenib) | Experimental | Participants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years. Receives: Drug: Donafenib |
| Arm B (active surveillance) | No intervention | Active surveillance of participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
One year recurrence-free survival (RFS) rate
The proportion from randomization to 1 year without recurrence.
Measured: 1 year
Secondary outcomes (3)
Recurrence-Free Survival (RFS )
The time from randomization to disease recurrence, or death from any cause (whichever occurs first).
Measured: 6 years
Recurrence-Free Survival rate (RFS rate)
The proportion from randomization to 2 years, 3 years or 5 years without recurrence.
Measured: 5 years
Overall Survival (OS)
The time from randomization to death from any cause.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start28 Aug 2024 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2032 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Changzhen Shang, MD, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581315
- Sponsor's protocol ID
- SYXKY-2024-666-02
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 3 Sep 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 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Donafenib as Adjuvant Therapy for Postoperative Patients With High-Risk Recurrent Hepatocellular Carcinoma: A Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06581315
- Acronym / sponsor ID
- SYXKY-2024-666-02
- Conditions
- Hepatocellular Carcinoma, Adjuvant Therapy
- Keywords
- Hepatocellular Carcinoma, Adjuvant Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 28 Aug 2024 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2032 (estimated)
- First posted
- 3 Sep 2024 (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 aims to evaluate the efficacy and safety of donafenib as adjuvant therapy for postoperative patients with high-risk recurrent Hepatocellular Carcinoma. This is a multicenter, randomized controlled study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Donafenib) | Experimental | Drug: DonafenibParticipants will receive Donafenib treatment until disease recurrence or unacceptable toxicity or up to 1 years. |
| Arm B (active surveillance) | No intervention | –Active surveillance of participants. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants underwent radical resection of hepatocellular carcinoma 4 weeks before randomization
- High Risk of recurrence as assessed by tumor characteristics
- Without any anti-tumor therapy before surgery, except preoperative TACE therapy, traditional Chinese medicine therapy and interferon therapy
- Child-Pugh Class A statu
- ECOG Performance Status of 0 or 1
Key exclusion criteria (6 listed)
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Evidence of residual or a history of spontaneous tumor rupture
- Recurrent HCC
- Prior received Liver transplantation
- Prior anti tumor therapy for treatment of HCC (including sorafenib or any other molecular therapy, anti-PD-1 antibody and other immunotherapies, FOLFOX systemic chemotherapy) is excluded
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: ZepsunDonafenib 100 mg twice daily (BID) | Drug | Arm A (Donafenib) |
Primary outcome
One year recurrence-free survival (RFS) rate
Time frame: 1 year
The proportion from randomization to 1 year without recurrence.
3 secondary outcomes
Recurrence-Free Survival (RFS )
Time frame: 6 years
Recurrence-Free Survival rate (RFS rate)
Time frame: 5 years
Overall Survival (OS)
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Changzhen Shang, MD principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donafenib in people with Hepatocellular Carcinoma and Adjuvant Therapy, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Sep 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Changzhen Shang, MD (+86-20-3407 0701, shchzh2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One year recurrence-free survival (RFS) rate (time frame: 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 3 Sep 2024.