Hepatocellular CarcinomaHCCNCT03398122
Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma
A study testing TACE and Apatinib in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE and Apatinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2017to 1 Apr 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-70 years old;
- initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
- Child-pugh liver function Rating: A level, B level;
- BCLC Staging as B / C period;
- before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:
- HB≥90 g/L;
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- ANC≥1.5x109/L;
- PLT≥60x109/L; ( 2 ) Biochemical Examination:
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- ALB≥29 g/L;
- ALT and AST<2.5*ULN;
- TBIL ≤ 2*ULN;
- Cr ≤ 1.5*ULN;
- women of childbearing age must be pregnancy tests before join in the group in 7 days;
- Participants volunteered to join this study should sign informed consent, with good compliance and follow-up.
Who cannot join
- Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus);
- hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous ( 5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure > 140 mmHg , diastolic pressure >90 mmHg );
- Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms );
- Follow NYHA Standard Ⅲ ~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) < 50% ;
- There are various factors affecting oral medication (e.g.inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption);
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- previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood ≥ ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy;
- before participating in this study There were abdominal fistula, gastrointestinal perforation or celiac abscess in the day;
- Coagulation dysfunction ( INR > 1.5 or prothrombin time ( PT ) > ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy;
- patients who have undergone central nervous system metastasis or known brain metastases;
- patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment;
- urine proteins are routinely shown ≥++ or confirmed 24 hour urine protein ration > 1.0 g ;
- before participating in the study 7 days use strong-effect in CYP3A4 inhibitor therapy, or prior to participating in the study 12 days use the strong-effect in CYP3A4 inducer Therapy;
- pregnant or lactating women who are not willing or unable to take effective contraceptive measures;
- A history of mental illness, or psychotropic substance abuse;
- Union HIV infected patients;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Zhi Guo, MD, 13920076145, cjr.guozhi@vip.163.com
Haipeng Yu, MD, 13352070835, jieruke@yahoo.com.cn
About this study
the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC
Read the detailed description
HCC The is a common malignancy in the world, especially in China. Advanced HCC treatment is difficult and the prognosis is poor, which is still a great challenge and threat to the medical profession. The advent of the molecular targeted drug, Sola, has made the treatment dilemma of advanced HCC a breakthrough, but the efficacy and economic health ratio is far from satisfactory. After Sola, many new molecular targeted drugs were studied, but failed.
Although multiple treatment options, but for HCC Patient-recommended treatment programs require systematic treatment and surgery, TACE , local ablation and radiotherapy and other multidisciplinary means of combination, the selection of appropriate patients, appropriate means and timing to achieve individualized treatment.
- Aptinib Union TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression;2. TACE induces hypoxia, leading to an increase in the number of hypoxia-inducing factors that increases VEGF and PDGFR , while VEGF the and PDGFR may be important factors that induce tumor recurrence by stimulating tumor angiogenesis.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Apatinib, advanced hepatocellular carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Also called chemoemtranscatherer arterial bolization
epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.
ApatinibDrug
Also called ai tan
a molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Apatinib combined with TACE | Experimental | patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks Receives: Procedure: TACE; Drug: Apatinib |
| chemoemtranscatherer arterial bolization | Placebo comparator | epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles. Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: one and a half year
Secondary outcomes (5)
OS
overall survival
Measured: one and a half year
TTP
time to progression
Measured: one and a half year
DCR
disease control rate
Measured: one and a half year
ORR
objective response rate
Measured: one and a half year
QOL
number of participants with treatment-related adverse events as assessed by EORTC QLQ-C30
Measured: one and a half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start14 Nov 2017
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Apr 2019 (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 Tianjin Medical University Cancer Institute and 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi Guo, MD, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398122
- Sponsor's protocol ID
- Ahead-HBH001
- Acronym
- HCC
- Status last verified
- Nov 2017
- First submitted
- 7 Jan 2018
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03398122
- Acronym / sponsor ID
- HCC / Ahead-HBH001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Apatinib, advanced hepatocellular carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 12 Jan 2018 (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.
the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC
Detailed description
HCC The is a common malignancy in the world, especially in China. Advanced HCC treatment is difficult and the prognosis is poor, which is still a great challenge and threat to the medical profession. The advent of the molecular targeted drug, Sola, has made the treatment dilemma of advanced HCC a breakthrough, but the efficacy and economic health ratio is far from satisfactory. After Sola, many new molecular targeted drugs were studied, but failed.
Although multiple treatment options, but for HCC Patient-recommended treatment programs require systematic treatment and surgery, TACE , local ablation and radiotherapy and other multidisciplinary means of combination, the selection of appropriate patients, appropriate means and timing to achieve individualized treatment.
- Aptinib Union TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression;2. TACE induces hypoxia, leading to an increase in the number of hypoxia-inducing factors that increases VEGF and PDGFR , while VEGF the and PDGFR may be important factors that induce tumor recurrence by stimulating tumor angiogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apatinib combined with TACE | Experimental | Procedure: TACE, Drug: Apatinibpatients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks |
| chemoemtranscatherer arterial bolization | Placebo comparator | Drug: Apatinibepirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age: 18-70 years old;
- initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
- Child-pugh liver function Rating: A level, B level;
- BCLC Staging as B / C period;
- before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:
Key exclusion criteria (16 listed)
- Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus);
- hepatobiliary cell carcinoma and mixed cell carcinoma are known; previous ( 5 year) or at the same time suffering from other incurable malignancies, except for the cured basal cell carcinoma of the skin and cervical carcinoma in situ;
- clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure > 140 mmHg , diastolic pressure >90 mmHg );
- Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms );
- Follow NYHA Standard Ⅲ ~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) < 50% ;
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 |
|---|---|---|
| TACEAlso: chemoemtranscatherer arterial bolizationepirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles. | Procedure or surgery | Apatinib combined with TACE |
| ApatinibAlso: ai tana molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor | Drug | Apatinib combined with TACE, chemoemtranscatherer arterial bolization |
Primary outcome
PFS
Time frame: one and a half year
progression free survival
5 secondary outcomes
OS
Time frame: one and a half year
TTP
Time frame: one and a half year
DCR
Time frame: one and a half year
ORR
Time frame: one and a half year
QOL
Time frame: one and a half year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2018.
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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.
Zhi Guo, MD study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE and Apatinib in people with Hepatocellular Carcinoma, run by Tianjin Medical University Cancer Institute and 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 15 inclusion and 16 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 12 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi Guo, MD (18622221211, cjr.guozhi@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: one and a half 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 12 Jan 2018.