Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC) (HCC)

February 6, 2017 updated by: Tianjin Medical University Cancer Institute and Hospital
The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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 our previous clinical studies, we intends to enlarge the sample size and make further observation for the efficacy and safety of apatinib in patients with advanced HCC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer institute and hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Before doing any research steps, the patient's informed consent must be obtained first.
  2. The diagnosis of HCC: histologic diagnosis or Alpha fetoprotein (AFP) with two kinds of imaging diagnosis.
  3. Patients of Barcelona stage(BCLC) C with first-line treatment failure or non tolerance to sorafenib.
  4. Ages of 18 to 75 years old.
  5. Child-Pugh score between 5-7 points, patients of Child-Pugh 7 points should be without ascites.
  6. Eastern Cooperative Oncology Group performance score (ECOG PS) is 0-1 point.

  7. Adequate organ function meeting the following:

    Hemoglobin(HBG)≧9.0g/dl Neutrophil count(ANC) ≧1,500/mm3 Platelet count(PLT)≧50,000/ul Total bilirubin (TBIL)< 2mg/dL (3mg/dL, Child-Pugh B) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 5×ULN (upper limit of normal) ALP (alkaline phosphatase ) < 4×ULN PT (prothrombin time) >50% or PT-INR<2.3, <6 seconds or greater than that of the control

  8. For patients taking warfarin, at least once a week to a close monitoring of the patients, until, according to the standard of treatment, at every time of medication, the subjects' INR measurements has been stable
  9. SCr (serum creatinine) <1.5×ULN
  10. For pregnant women, the results of serum pregnancy tests must be negative within 14 days before initiation of treatment.
  11. All men and women who participated in the study had to take reliable contraceptive measures within the trial and two weeks of after the trial.

Exclusion Criteria:

  1. Patients of Child-Pugh 7 has serious uncontrolled ascites.
  2. Patients with serious cardiovascular disease.
  3. Patients with high blood pressure of unable to control.
  4. Patients has the history of HIV (human immunodeficiency virus) infection.
  5. Active clinical severe infection (> 2, NCI-CTCAE version 3).
  6. Need to drug treatment of patients with epilepsy (such as steroid or antiepileptic drugs)
  7. Has a history of allogeneic organ transplantation.
  8. Patients with a history of physical signs or have a bleeding.
  9. Patients undergoing renal dialysis.
  10. Metastatic liver cancer.
  11. Patients with uncontrollable ascites.
  12. Patients with encephalopathy.
  13. Patients has history of gastrointestinal bleeding period of 30 days before join the study.
  14. Patients with a history of esophagus varicosity burst hemorrhage, then not effective treatment or therapy to prevent recurrence of bleeding.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Apatinib
a molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
Drug: Apatinib
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Other Names:
  • apatinib mesylate tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Objective Response Rate(ORR)
Time Frame: one year
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Disease Control Rate (DCR)
Time Frame: one year
one year
Progression free survival (PFS)
Time Frame: one year
one year
Overall survival (OS)
Time Frame: one year
one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life]
Time Frame: one year
one year
Incidence of Treatment-Emergent Adverse Events [Safety]
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Medical University Cancer Institute and Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ti Zhang, Tianjin Medical University Cancer Institute & Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AHEAD-HBH002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

the plan to share IPD is under consideration.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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