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

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Apatinib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring apatinib, advanced hepatocellular carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Tianjin Medical University Cancer Institute and HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Apatinib

Arm Description

a molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.

Outcomes

Primary Outcome Measures

Objective Response Rate(ORR)

Secondary Outcome Measures

Disease Control Rate (DCR)

Progression free survival (PFS)

Overall survival (OS)

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life]

Incidence of Treatment-Emergent Adverse Events [Safety]

Full Information

NCT ID

NCT03046979

First Posted

January 16, 2017

Last Updated

February 6, 2017

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03046979

Brief Title

Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)

Acronym

HCC

Official Title

Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of apatinib in patients with advanced HCC.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

apatinib, advanced hepatocellular carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib

Arm Type

Experimental

Arm Description

a molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

apatinib mesylate tablets

Intervention Description

500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Primary Outcome Measure Information:

Title

Objective Response Rate(ORR)

Time Frame

one year

Secondary Outcome Measure Information:

Title

Disease Control Rate (DCR)

Time Frame

one year

Title

Progression free survival (PFS)

Time Frame

one year

Title

Overall survival (OS)

Time Frame

one year

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0[Quality of life]

Time Frame

one year

Title

Incidence of Treatment-Emergent Adverse Events [Safety]

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ti Zhang, MD

Phone

13920350428

zhangti@tjmuch.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hui-Kai Li, MD

Phone

13820377269

tjchlhk@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ti Zhang

Organizational Affiliation

Tianjin Medical University Cancer Institute & Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute and Hospital

City

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

TI ZHANG, MD

Phone

+862223340123

Ext

3092

zhangti@tjmuch.com

First Name & Middle Initial & Last Name & Degree

Huikai Li, MD

Phone

+862223340123

Ext

3091

lihuikai@tjmuch.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

the plan to share IPD is under consideration.

Citations:

PubMed Identifier

33145266

Citation

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.

Results Reference

derived

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Study of Apatinib in Advanced Hepatocellular Carcinoma(HCC)

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