Hepatocellular CarcinomaPhase 3NCT03192644
The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
A Phase 3 study testing TAI, TACE and epidoxorubicin and cisplatin and lipiodol in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TAI, TACE and epidoxorubicin and cisplatin and lipiodol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 31 Dec 2024
- 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
- older than 18 years old and younger than 75 years;
- ECOG PS<3;
- proven hepatocellular carcinoma with PVTT according pathological examination;
- not previous treated for tumor;
- tumor and tumor thrombosis were removed in operation;
- no recurrence occurence at 4 to 7 weeks after surgery;
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- the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin<3-times upper limit of normal; ALT<5-times upper limit of normal; AST<5-times upper limit of normal; serum creatine<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3;
- sign up consent;
- unrolled by other clinical trials about hepatocellular carcinoma.
Who cannot join
- cannot tolerate TACE or TAI;
- CNS or bone metastasis exits;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
- be treated before (interferon included);
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- known history of HIV infection;
- known history of drug or alcohol abuse;
- have GI hemorrhage or cardiac/brain vascular events within 30 days;
- pregnancy;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center of Sun Yat-Sen University
Guangzhou
Shaohua Li, MD, lishaoh@sysucc.org.cn
About this study
To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TAI, TACE, epidoxorubicin and cisplatin and lipiodol, mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAIProcedure or surgery
transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
TACEProcedure or surgery
transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol
epidoxorubicin and cisplatin and lipiodolDrug
epidoxorubicin and cisplatin and lipiodol
mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)Drug
oxaliplatin, calcium folinate, and 5-FU
| Study group | Role | What they receive |
|---|---|---|
| Group A (TAI) | Experimental | Not described Receives: Procedure: TAI; Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) |
| Group B (TACE) | Active comparator | Not described Receives: Procedure: TACE; Drug: epidoxorubicin and cisplatin and lipiodol |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence-free survival (RFS)
recurrence-free survival
Measured: From date of randomization until the date of recurrence, assessed up to 60 months
Secondary outcomes (2)
recurrence rate
recurrence rate
Measured: 1 year, 2 year, 3 year, 5 year after surgery
Overall survival (OS)
overall survival
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-ping Guo, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192644
- Sponsor's protocol ID
- B2017-004-01
- Status last verified
- Jan 2017
- First submitted
- 16 Jun 2017
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.
- ClinicalTrials.gov ID
- NCT03192644
- Acronym / sponsor ID
- B2017-004-01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Jun 2017 (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.
To compare the impact on recurrence risk of adjuvant TAI and adjuvant TACE for patients with HCC and PVTT after hepatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (TAI) | Experimental | Procedure: TAI, Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) |
| Group B (TACE) | Active comparator | Procedure: TACE, Drug: epidoxorubicin and cisplatin and lipiodol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- older than 18 years old and younger than 75 years;
- ECOG PS<3;
- proven hepatocellular carcinoma with PVTT according pathological examination;
- not previous treated for tumor;
- tumor and tumor thrombosis were removed in operation;
Key exclusion criteria (10 listed)
- cannot tolerate TACE or TAI;
- CNS or bone metastasis exits;
- known history of other malignancy;
- be allergic to related drugs;
- underwent organ transplantation before;
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 |
|---|---|---|
| TAItransarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU) | Procedure or surgery | Group A (TAI) |
| TACEtransarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol | Procedure or surgery | Group B (TACE) |
| epidoxorubicin and cisplatin and lipiodolepidoxorubicin and cisplatin and lipiodol | Drug | Group B (TACE) |
| mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)oxaliplatin, calcium folinate, and 5-FU | Drug | Group A (TAI) |
Primary outcome
recurrence-free survival (RFS)
Time frame: From date of randomization until the date of recurrence, assessed up to 60 months
recurrence-free survival
2 secondary outcomes
recurrence rate
Time frame: 1 year, 2 year, 3 year, 5 year after surgery
Overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 3 study testing TAI, TACE and epidoxorubicin and cisplatin and lipiodol in people with Hepatocellular Carcinoma, 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Shaohua, MD (+86, lishaoh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence-free survival (RFS) (time frame: From date of randomization until the date of recurrence, assessed up to 60 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 20 Jun 2017.