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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

30

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

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

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
Intervention / Treatment
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

Outcome Measure
Time Frame
Objective Response Rate(ORR)
Time Frame: one year
one year

Secondary Outcome Measures

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

Tianjin Medical University Cancer Institute and Hospital

Investigators

  • 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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Estimate)

February 8, 2017

Last Update Submitted That Met QC Criteria

February 6, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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