Hepatocellular CarcinomaNCT03066557
Study of the Combination of TACE With Apatinib in Patients With Hepatocellular Carcinoma
A study testing TACE and Apatinib and TACE in people with Hepatocellular Carcinoma, run by Jiangsu Cancer Institute & Hospital.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. 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?
- TACE and Apatinib and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2017to 31 Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 - 75 years old;
- Must be strictly in accordance with the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition). According to clinical diagnosis standard or confirmed by histopathology or cytology, the patients with advanced primary liver cancer who can't be?removed surgically, and can't accept palliative surgery or radiation therapy, and have at least one measurable lesions;The biggest tumor 10 cm or less;
- Refuse the treatment of sorafenib;
- The Child - Pugh( liver function grade): grade A or better grade of B (≤7 points);
- BCLC stage for B or C;
- Within 1 week before into the study,ECOG PS0-1;
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- The expected lifetime of patients should be equal to or more than 12 weeks;
- The main viscera function of patients must be normal, and should meet the following requirements:
- Blood routine examination must meet: HB≥90 g/L, ANC≥1.5×10^9/L, PLT≥60×10^9/L;
- Biochemical examination should meet the following criteria: ALB ≥29 g/L, ALT and AST<5xULN, TBIL ≤1.5xULN, creatinine≤1.5xULN (Only one of albumin and bilirubin can be 2 points in the rating of Child-Pugh);
- The patients are willing to join in this study, and have signed the informed consent. The patients have good adherence, and are willing to cooperate with the follow-up.
Who cannot join
- Patients have received radiotherapy or chemotherapy within four weeks before the study;
- In the past (within 5 years) or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted;
- Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg);
- Patients who are diagnosed with II or higher level of myocardial ischemia, myocardial infarction, uncontrolled arrhythmia(including QTc interval prolongation men> 450 ms, female> 470 ms);
- There are many factors which can influence the oral drug absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction, which can significantly affect the drug taking and absorption);
- Within 6 months in the past,the patients have a history of gastrointestinal bleeding or a gastrointestinal bleeding tendency, for example,there is a risk of bleeding of esophageal varicose veins, local active ulcerative lesions, defecate occult blood ≥ (+ +)(+) shall not be admitted into the study;
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- within 28 days before being admitted into the study, there is abdominal fistula, gastrointestinal perforation or abdominal abscess;
- Blood coagulation function is abnormal (INR>1.5 or PT> ULN+4s), and the patients are able to be faced with a bleeding tendency or being treated with thrombolysis and anticoagulation;
- Has been diagnosed with ?the central nervous system metastases or the brain metastases has been known;
- There are past medical history or history of present illness of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug related pneumonia,pulmonary function test suggests there is objective evidence of severely damaged lung function;
- Urine routine inspection suggests that the urine protein ≥++;24 hours urine protein examination>1.0 g;
- Within 7 days before being admitted into the study,patients have received a potent CYP3A4 inhibitor treatment, or within 12 days before being admitted into the study,patients have received potent CYP3A4 inducers treatment;
- Pregnant or lactating women;Patients with fertility are unwilling or unable to take effective contraceptive measures;
- With a mental illness, or has a history of psychiatric drugs abuse;
- Patients with HIV infection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Apatinib in Patients With Hepatocellular Carcinoma Trial
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of previous clinical studies, we intend to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its incidence matches mortality, reflecting the poor prognosis of this disease. The surgical resection rate of HCC is low, and the prognosis is poor. Although transarterial chemoembolization (TACE) is the main treatment for HCC patients who are not candidates for surgical resection, it is not considered a curative procedure. For HCC, poor TACE efficacy or TACE failure may be related to tumor angiogenesis of the residual disease. Among the many regulatory factors in tumor angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular endothelial growth factor (VEGF) play vital roles in this process.
Sorafenib is the first systemic treatment drug, which has been approved by the FDA for advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity, Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor growth inhibitory activity on Hepatocellular carcinoma, this study aims to further verify the efficacy and safety of Apatinib for hepatocellular carcinoma patients who are not candidates for curative surgery, the primary endpoint is Progression Free Survival (PFS).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE and Apatinib, TACE
- Keywords
- Hepatocellular Carcinoma, Apatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE and ApatinibProcedure or surgery
Also called Aitan
TACE and Apatinib 250mg po qd
TACEProcedure or surgery
TACE
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | TACE and Apatinib Receives: Procedure: TACE and Apatinib |
| control group | Experimental | TACE alone Receives: Procedure: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: 2 years
Secondary outcomes (5)
TTP
Time To Progress
Measured: 2 years
OS
Overall Survival
Measured: 2 years
DCR
Disease Control Rate
Measured: 2 years
ORR
Objective Response Rate
Measured: 2 years
QoL
Quality of Life
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 posted28 Feb 2017
- Study start15 Mar 2017 (estimated)
- Primary completion30 Jun 2018 (estimated)
- Study completion31 Dec 2018 (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.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Cancer Institute & Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Shixi Chen, Jiangsu Cancer Institute & Hospital
- Investigators
- Feng Jifeng, Doctor, Study chair, Jiangsu Cancer Institute & Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066557
- Sponsor's protocol ID
- ANIMATE-JS-201
- Status last verified
- Feb 2017
- First submitted
- 20 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within six months after the trial complete
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Combination of Transcatheter Arterial Chemoembolization (TACE) With Apatinib in Patients With Hepatocellular Carcinoma Trial
- ClinicalTrials.gov ID
- NCT03066557
- Acronym / sponsor ID
- ANIMATE-JS-201
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Apatinib
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangsu Cancer Institute & HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 15 Mar 2017 (estimated)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 28 Feb 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.
Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is lack of effective drugs for systemic treatment of HCC. Currently, Sorafenib is the only choice approved by FDA for advanced HCC, although it prolongs the survival for less than 3 months. The treatment of advanced HCC still has a long way to go.
At present, the relevant phase II and phase III clinical studies of apatinib on advanced HCC are ongoing. Based on our important discovery of previous clinical studies, we intend to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.
Detailed description
Hepatocellular carcinoma (HCC) is one of the lethal human cancers worldwide and its incidence matches mortality, reflecting the poor prognosis of this disease. The surgical resection rate of HCC is low, and the prognosis is poor. Although transarterial chemoembolization (TACE) is the main treatment for HCC patients who are not candidates for surgical resection, it is not considered a curative procedure. For HCC, poor TACE efficacy or TACE failure may be related to tumor angiogenesis of the residual disease. Among the many regulatory factors in tumor angiogenesis, hypoxia-inducible factor-1α (HIF-1α) and vascular endothelial growth factor (VEGF) play vital roles in this process.
Sorafenib is the first systemic treatment drug, which has been approved by the FDA for advanced HCC. In order to find an new VEGFR-inhibitor with better effect and lower toxicity, Jiangsu Hengrui Medicine Co., Ltd. developed Apatinib, a high-performance VEGFR-2 tyrosine kinase inhibitor. Apatinib plays anti angiogenic effect in the treatment of malignant tumor mainly through inhibition of VEGFR-2, in vivo and in vitro experiments showed good tumor growth inhibitory activity on Hepatocellular carcinoma, this study aims to further verify the efficacy and safety of Apatinib for hepatocellular carcinoma patients who are not candidates for curative surgery, the primary endpoint is Progression Free Survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Procedure: TACE and ApatinibTACE and Apatinib |
| control group | Experimental | Procedure: TACETACE alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18 - 75 years old;
- Must be strictly in accordance with the "guidelines for primary liver cancer diagnosis and treatment" (2011 edition). According to clinical diagnosis standard or confirmed by histopathology or cytology, the patients with advanced primary liver cancer who can't be?removed surgically, and can't accept palliative surgery or radiation therapy, and have at least one measurable lesions;The biggest tumor 10 cm or less;
- Refuse the treatment of sorafenib;
- The Child - Pugh( liver function grade): grade A or better grade of B (≤7 points);
- BCLC stage for B or C;
Key exclusion criteria (15 listed)
- Patients have received radiotherapy or chemotherapy within four weeks before the study;
- In the past (within 5 years) or at the same time,patients were diagnosed with other malignant tumor which have not been cured. As for skin basal cell carcinoma and cervical carcinoma in situ,they can be excepted;
- Patients who are diagnosed with hypertension which cant be reduced to normal range via antihypertensive drug treatment(systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg);
- Patients who are diagnosed with II or higher level of myocardial ischemia, myocardial infarction, uncontrolled arrhythmia(including QTc interval prolongation men> 450 ms, female> 470 ms);
- There are many factors which can influence the oral drug absorption (such as unable to swallow, chronic diarrhea and intestinal obstruction, which can significantly affect the drug taking and absorption);
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 |
|---|---|---|
| TACE and ApatinibAlso: AitanTACE and Apatinib 250mg po qd | Procedure or surgery | study group |
| TACETACE | Procedure or surgery | control group |
Primary outcome
PFS
Time frame: 2 years
progression free survival
5 secondary outcomes
TTP
Time frame: 2 years
OS
Time frame: 2 years
DCR
Time frame: 2 years
ORR
Time frame: 2 years
QoL
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: Yes. Within six months after the trial complete
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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.
Feng Jifeng, Doctor study chair
Jiangsu Cancer Institute & Hospital
Questions about this trial
What is this clinical trial studying?
A study testing TACE and Apatinib and TACE in people with Hepatocellular Carcinoma, run by Jiangsu Cancer Institute & Hospital.
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 11 inclusion and 15 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Shixi, Bachelor (+86-13505192984, chenshixi2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (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 28 Feb 2017.