Hepatocellular CarcinomaPhase 3NCT02867280
Sorafenib Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection
A Phase 3 study testing Sorafenib in people with Hepatocellular Carcinoma and Recurrence, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective multicenter non-randomized controlled study evaluates the efficacy and safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with microvascular invasion after radical resection compared to conventional therapies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Recurrence
- What is being tested?
- Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 31 Jan 2020
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Hepatocellular carcinoma confirmed by pathology
- No macroscopic tumor thrombus vascular invasion and distant metastasis
- R0 resection（clean resection margin both macroscopically and microscopically）
- MVI confirmed by pathology
- ECOG 0-1
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- Child-Pugh stage A
- WBC > 3×10E9/L；HB > 90 G/L；PLT > 50×10E9/L
- ALT，AST not exceeding 5 times of the upper limit of normal value；CRE，TBIL not exceeding 1.5 times of the upper limit of normal value
Who cannot join
- Tumor rupture or invading to adjacent organs
- Patients who underwent liver transplantation
- Past history of or simultaneously receiving other anti-cancer therapy (such as TACE, chemotherapy, radiotherapy and others）and immune cell infusion therapy
- Uncontrolled cardiovascular and cerebrovascular diseases
- History of gastrointestinal bleeding within 6 months
- Active infection other than HBV, HCV
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- Postoperative complications, not suitable to take Sorafenib (such as long term use of drainage due to bile leakage, poor wound healing and others)
- Confirmed liver cancer recurrence or metastasis within 4 weeks after hepatectomy
- Poor compliance, cannot adhere to regular follow up
- Diagnosed with other original malignant tumors other than HCC
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Non-randomized Controlled Study of Sorafenib (Nexavar) Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection
This prospective multicenter non-randomized controlled study evaluates the efficacy and safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with microvascular invasion after radical resection compared to conventional therapies.
Read the detailed description
The study is a multicenter, non-randomized, open-label, blank controlled study which initiated by Investigators. The study population include patients without macroscopic vascular invasion and distant metastasis, undergoing R0 resection, postoperative pathology confirming hepatocellular carcinoma with microvascular invasion (MVI) (BCLC A or B stage; T2 or part T3aN0M0). The primary end point of this study is recurrence free survival（RFS）at the 2nd postoperative years, and the secondary end points include postoperative median time to recurrence (TTR), 1-year, 3-years, 5-years postoperative recurrence free survival (RFS), 3-years, 5-years postoperative overall survival, and safety and tolerance of sorafenib as an adjuvant therapy for HCC. Patients in the treatment group will start Sorafenib within 4 weeks after hepatectomy at doze of 400mg per day, and last continuously for 2 years, or until disease progression. Patients in the control group will take regular treatment with no use of Sorafenib. Both groups are forbid receiving postoperative anti-cancer therapy such as adjuvant radiotherapy, chemotherapy and TACE. Patients of both groups should receive antiviral therapy according to guidelines. Chinese traditional medicine and nutritional support can be used without limitation, and the information of concomitant drug need to be recorded for further analysis. Treatment for relieve drug related AEs can be used as needed. Patients of both groups will be treated with best clinical practice as routine after confirmed recurrence/metastasis, and the information of further treatment need to be recorded and follow-up till death.
- Conditions
- Hepatocellular Carcinoma, Recurrence
- Being tested
- Sorafenib
- Keywords
- Sorafenib, Microvascular invasion, adjuvant therapy, hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorafenibDrug
Also called Nexavar
red round tablet
| Study group | Role | What they receive |
|---|---|---|
| Sorafenib | Experimental | Sorafenib (Nexavar) 200mg tablet, 2 tablets oral daily for 2 years, starting within 4weeks after hepatectomy. Regular treatment combined. Receives: Drug: Sorafenib |
| Control | No intervention | No use of Sorafenib (Nexavar). Regular treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence free survival
To determine the recurrence free survival rate at 2 years after hepatectomy
Measured: 2 years
Secondary outcomes (6)
Time To Recurrence
To determine the median postoperative time to recurrence
Measured: From date of liver resection until the date of first documented relapse, assessed up to 5 years
Recurrence rate
To determine the recurrence rate within 2 years after hepatectomy
Measured: 2 years
Recurrence free survival
To determine the recurrence free survival at postoperative 1-year, 3-year, and 5-year
Measured: 1year, 3years, 5 years
Overall survival
To determine the overall survival at postoperative 3-year and 5-year
Measured: 3 years, 5 years
Incidence of Treatment-related Adverse Events measures using CTCAE v4.0
measures using CTCAE v4.0
Measured: 2 years
Incidence of dose modification of sorafenib due to adverse events.
The actual total dose of sorafenib for every patients will be collected as well.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start1 Jun 2016
- Primary completion31 Aug 2019
- Study completion31 Jan 2020
Why it stopped: Midterm analysis showed negative results.
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 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Min-Shan, Sun Yat-sen University
- Investigators
- Minshan Chen, PHD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867280
- Sponsor's protocol ID
- Sorafenib-MVI
- Status last verified
- Feb 2020
- First submitted
- 10 Jul 2016
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Non-randomized Controlled Study of Sorafenib (Nexavar) Treatment in Patients With Hepatocellular Carcinoma With Microvascular Invasion After Radical Resection
- ClinicalTrials.gov ID
- NCT02867280
- Acronym / sponsor ID
- Sorafenib-MVI
- Conditions
- Hepatocellular Carcinoma, Recurrence
- Keywords
- Sorafenib, Microvascular invasion, adjuvant therapy, hepatocellular carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Midterm analysis showed negative results.
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 15 Aug 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.
This prospective multicenter non-randomized controlled study evaluates the efficacy and safety of treatment with Sorafenib (Nevaxar) in patients with hepatocellular carcinoma with microvascular invasion after radical resection compared to conventional therapies.
Detailed description
The study is a multicenter, non-randomized, open-label, blank controlled study which initiated by Investigators. The study population include patients without macroscopic vascular invasion and distant metastasis, undergoing R0 resection, postoperative pathology confirming hepatocellular carcinoma with microvascular invasion (MVI) (BCLC A or B stage; T2 or part T3aN0M0). The primary end point of this study is recurrence free survival（RFS）at the 2nd postoperative years, and the secondary end points include postoperative median time to recurrence (TTR), 1-year, 3-years, 5-years postoperative recurrence free survival (RFS), 3-years, 5-years postoperative overall survival, and safety and tolerance of sorafenib as an adjuvant therapy for HCC. Patients in the treatment group will start Sorafenib within 4 weeks after hepatectomy at doze of 400mg per day, and last continuously for 2 years, or until disease progression. Patients in the control group will take regular treatment with no use of Sorafenib. Both groups are forbid receiving postoperative anti-cancer therapy such as adjuvant radiotherapy, chemotherapy and TACE. Patients of both groups should receive antiviral therapy according to guidelines. Chinese traditional medicine and nutritional support can be used without limitation, and the information of concomitant drug need to be recorded for further analysis. Treatment for relieve drug related AEs can be used as needed. Patients of both groups will be treated with best clinical practice as routine after confirmed recurrence/metastasis, and the information of further treatment need to be recorded and follow-up till death.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sorafenib | Experimental | Drug: SorafenibSorafenib (Nexavar) 200mg tablet, 2 tablets oral daily for 2 years, starting within 4weeks after hepatectomy. Regular treatment combined. |
| Control | No intervention | –No use of Sorafenib (Nexavar). Regular treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-75 years
- Hepatocellular carcinoma confirmed by pathology
- No macroscopic tumor thrombus vascular invasion and distant metastasis
- R0 resection（clean resection margin both macroscopically and microscopically）
- MVI confirmed by pathology
Key exclusion criteria (10 listed)
- Tumor rupture or invading to adjacent organs
- Patients who underwent liver transplantation
- Past history of or simultaneously receiving other anti-cancer therapy (such as TACE, chemotherapy, radiotherapy and others）and immune cell infusion therapy
- Uncontrolled cardiovascular and cerebrovascular diseases
- History of gastrointestinal bleeding within 6 months
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 |
|---|---|---|
| SorafenibAlso: Nexavarred round tablet | Drug | Sorafenib |
Primary outcome
Recurrence free survival
Time frame: 2 years
To determine the recurrence free survival rate at 2 years after hepatectomy
6 secondary outcomes
Time To Recurrence
Time frame: From date of liver resection until the date of first documented relapse, assessed up to 5 years
Recurrence rate
Time frame: 2 years
Recurrence free survival
Time frame: 1year, 3years, 5 years
Overall survival
Time frame: 3 years, 5 years
Incidence of Treatment-related Adverse Events measures using CTCAE v4.0
Time frame: 2 years
Incidence of dose modification of sorafenib due to adverse events.
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Midterm analysis showed negative results.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- 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. This study is not recruiting at the moment.
Minshan Chen, PHD principal investigator
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 Phase 3 study testing Sorafenib in people with Hepatocellular Carcinoma and Recurrence, run by 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 9 inclusion and 10 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: stopped early, as of the sponsor's last update on 11 Feb 2020. 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 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 was stopped early (reason given: Midterm analysis showed negative results.). Results are not available in the source record.
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?
Recurrence free survival (time frame: 2 years). 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 11 Feb 2020.