- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510416
Efficacy and Safety of Apatinib Combined With TACE in Patients With Hepatocellular Carcinoma
April 26, 2018 updated by: Shanghai Zhongshan Hospital
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 .
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: zhiping Yan, MD
- Phone Number: 13681971205
- Email: yan.zhiping@zs-hospital.sh.cn
Study Contact Backup
- Name: wei Zhang, MD
- Phone Number: 13917737593
- Email: zhang.wei6@zs-hospital.sh.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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).
Exclusion Criteria:
- 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)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: apatinib combined with TACE
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.
|
apatinib is a kind of Inhibitor of VEGFR-2
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From the date of first procedure of apatinib combined with TACE until the time when the disease progresses, assessed up to 14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From the date of randomization until the date of death from any cause, assessed up to 14 months
|
From the date of randomization until the date of death from any cause
|
From the date of randomization until the date of death from any cause, assessed up to 14 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: zhiping Yan, MD, Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
May 1, 2018
Primary Completion (ANTICIPATED)
June 30, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
April 17, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (ACTUAL)
April 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 27, 2018
Last Update Submitted That Met QC Criteria
April 26, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Apatinib
Other Study ID Numbers
- ZS-IR-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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