Hepatocellular Carcinoma Refractory to Transcatheter Arterial ChemoembolizationPhase 2NCT03510416
Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma
A Phase 2 study testing Apatinib and TACE in people with Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization, run by Shanghai Zhongshan Hospital.
Trial summary
Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization
- What is being tested?
- Apatinib and TACE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 31 Dec 2019
- Phase
- Phase 2
- 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: 18-70 years old;Estimated survival time≥12 weeks
- Histologicaly and cytologicaly diagnosed as Hepatocellular carcinoma of the liver ( HCC ) and with At least one imaging examination of measurable lesions (RECIST), CT or MR scan Long diameter of tumor ≥ 10 mm.Target lesion without Local treatment
- Child-pugh liver function Rating: A level, B level
- BCLC Staging as B / C period
- ECOG 0-1
- Have progressed after at least twice TACE
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- The main organ function is normal, and meet the following standards:(1)The standard of blood routine examination should be consistent: HB≥90 g/L, ANC≥1.5×10^9/L, PLT≥60×10^9/L; (2)Biochemical tests should meet the following criteria: ALB ≥29 g/L；TBIL<2'ULN, ALT and AST<5'ULN,Cr ≤ 1.5*ULN
- Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib
- Patients voluntarily entered the study and signed informed consent form (ICF).
Who cannot join
- Received Any local treatment other than TACE (including but not limited to surgery, radiotherapy, hepatic arterial embolization, hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within four weeks before randomization
- Participated in other cancer drug clinical trials within four weeks before randomization
- 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
- have received or Prepared for liver transplantation
- A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; or Child-Pugh>2；
- Patients with uncontrol hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg, despite optimal drug therapy)
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- Suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation > 450 ms male, female, 470 MS) and Cardiac insufficiency
- According to NYHA standard, III ~ IV cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) < 50%
- There are several factors that affect oral medicine,such as unable to swallow, chronic diarrhea and intestinal obstruction
- Before randomization within 6 months had significant bleeding clinical significance or definite bleeding tendency, such as gastrointestinal bleeding, bleeding gastric ulcer, baseline fecal occult blood and above, or suffering from vasculitis
- History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 28 days before randomization
- Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
- Central nervous system with symptoms of metastasis
- there is typical interstitial pneumonia or pulmonary fibrosis
- Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders
- 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
- Patients with allergies to research drugs
- Other patients who were considered unsuitable for inclusion by physicians.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization
Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization .
Read the detailed description
Aptinib combined with TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression.Efficacy and safety of apatinib combined with TACE in patients with hepatocellular carcinoma refractory to transcatheter arterial chemoembolization.
- Keywords
- apatinib，TACE， hepatocellular carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
apatinib is a kind of Inhibitor of VEGFR-2
TACERadiation
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
| Study group | Role | What they receive |
|---|---|---|
| apatinib combined with TACE | Experimental | Apatinib is administered after TACE 4-7 days, and TACE treatment is performed after discontinuation of apatinib for 4 days.Every 28 days is a cycle. Receives: Drug: Apatinib; Radiation: TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time To Progression
Time to progression is defined as stable with treatment of apatinib combined with TACE after enrollment until lesions are defined as disease progression.
Measured: From the date of first procedure of apatinib combined with TACE until the time when the disease progresses, assessed up to 14 months
Secondary outcomes (1)
Overall Survival
From the date of randomization until the date of death from any cause
Measured: From the date of randomization until the date of death from any cause, assessed up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Jun 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Refractory to Transcatheter Arterial ChemoembolizationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhiping Yan, MD, Study director, Department of Interventional Radiology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510416
- Sponsor's protocol ID
- ZS-IR-2018
- Status last verified
- Apr 2018
- First submitted
- 17 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- 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 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization
- ClinicalTrials.gov ID
- NCT03510416
- Acronym / sponsor ID
- ZS-IR-2018
- Keywords
- apatinib，TACE， hepatocellular carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Apr 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.
Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization .
Detailed description
Aptinib combined with TACE can be generated through embolization and angiogenesis by the dual target of vascular suppression.Efficacy and safety of apatinib combined with TACE in patients with hepatocellular carcinoma refractory to transcatheter arterial chemoembolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| apatinib combined with TACE | Experimental | Drug: Apatinib, Radiation: TACEApatinib is administered after TACE 4-7 days, and TACE treatment is performed after discontinuation of apatinib for 4 days.Every 28 days is a cycle. |
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: 18-70 years old;Estimated survival time≥12 weeks
- Histologicaly and cytologicaly diagnosed as Hepatocellular carcinoma of the liver ( HCC ) and with At least one imaging examination of measurable lesions (RECIST), CT or MR scan Long diameter of tumor ≥ 10 mm.Target lesion without Local treatment
- Child-pugh liver function Rating: A level, B level
- BCLC Staging as B / C period
- ECOG 0-1
Key exclusion criteria (20 listed)
- Received Any local treatment other than TACE (including but not limited to surgery, radiotherapy, hepatic arterial embolization, hepatic arterial infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within four weeks before randomization
- Participated in other cancer drug clinical trials within four weeks before randomization
- 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
- have received or Prepared for liver transplantation
- A serous cavity effusion (including hydrothorax, ascites, pericardial effusion) with local symptoms requiring local treatment; or Child-Pugh>2；
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 |
|---|---|---|
| Apatinibapatinib is a kind of Inhibitor of VEGFR-2 | Drug | apatinib combined with TACE |
| TACEEpirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE. | Radiation | apatinib combined with TACE |
Primary outcome
Time To Progression
Time frame: From the date of first procedure of apatinib combined with TACE until the time when the disease progresses, assessed up to 14 months
Time to progression is defined as stable with treatment of apatinib combined with TACE after enrollment until lesions are defined as disease progression.
1 secondary outcome
Overall Survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: No
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.
zhiping Yan, MD study director
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and TACE in people with Hepatocellular Carcinoma Refractory to Transcatheter Arterial Chemoembolization, run by Shanghai Zhongshan 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 9 inclusion and 20 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 27 Apr 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 zhiping Yan, MD (13681971205, yan.zhiping@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time To Progression (time frame: From the date of first procedure of apatinib combined with TACE until the time when the disease progresses, assessed up to 14 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 27 Apr 2018.