Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)
HCC
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hepatocellular-carcinoma
Started Dec 2016
Shorter than P25 for phase_2 hepatocellular-carcinoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 8, 2017
January 1, 2017
1 year
January 16, 2017
February 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate(ORR)
one year
Secondary Outcomes (5)
Disease Control Rate (DCR)
one year
Progression free survival (PFS)
one year
Overall survival (OS)
one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life]
one year
Incidence of Treatment-Emergent Adverse Events [Safety]
one year
Study Arms (1)
Apatinib
EXPERIMENTALa molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
Interventions
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- Before doing any research steps, the patient's informed consent must be obtained first.
- The diagnosis of HCC: histologic diagnosis or Alpha fetoprotein (AFP) with two kinds of imaging diagnosis.
- Patients of Barcelona stage(BCLC) C with first-line treatment failure or non tolerance to sorafenib.
- Ages of 18 to 75 years old.
- Child-Pugh score between 5-7 points, patients of Child-Pugh 7 points should be without ascites.
- Eastern Cooperative Oncology Group performance score (ECOG PS) is 0-1 point.
- 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
- 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
- SCr (serum creatinine) \<1.5×ULN
- For pregnant women, the results of serum pregnancy tests must be negative within 14 days before initiation of treatment.
- 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.
You may not qualify if:
- Patients of Child-Pugh 7 has serious uncontrolled ascites.
- Patients with serious cardiovascular disease.
- Patients with high blood pressure of unable to control.
- Patients has the history of HIV (human immunodeficiency virus) infection.
- Active clinical severe infection (\> 2, NCI-CTCAE version 3).
- Need to drug treatment of patients with epilepsy (such as steroid or antiepileptic drugs)
- Has a history of allogeneic organ transplantation.
- Patients with a history of physical signs or have a bleeding.
- Patients undergoing renal dialysis.
- Metastatic liver cancer.
- Patients with uncontrollable ascites.
- Patients with encephalopathy.
- Patients has history of gastrointestinal bleeding period of 30 days before join the study.
- Patients with a history of esophagus varicosity burst hemorrhage, then not effective treatment or therapy to prevent recurrence of bleeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tianjin Medical University Cancer Institute and Hospital
Tianjin, 300060, China
Related Publications (1)
Hou Z, Zhu K, Yang X, Chen P, Zhang W, Cui Y, Zhu X, Song T, Li Q, Li H, Zhang T. Apatinib as first-line treatment in patients with advanced hepatocellular carcinoma: a phase II clinical trial. Ann Transl Med. 2020 Sep;8(17):1047. doi: 10.21037/atm-20-2990.
PMID: 33145266DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ti Zhang
Tianjin Medical University Cancer Institute and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2017
First Posted
February 8, 2017
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
February 8, 2017
Record last verified: 2017-01