NCT03398122

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
248

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

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

November 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 12, 2018

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

January 7, 2018

Last Update Submit

January 11, 2018

Conditions

Hepatocellular Carcinoma

Keywords

Apatinibadvanced hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • PFS

    progression free survival

    one and a half year

Secondary Outcomes (5)

  • OS

    one and a half year

  • TTP

    one and a half year

  • DCR

    one and a half year

  • ORR

    one and a half year

  • QOL

    one and a half year

Study Arms (2)

Apatinib combined with TACE

EXPERIMENTAL

patients received Aptinib, 250 mg daily after TACE treatment, for 4-6 weeks

Procedure: TACEDrug: Apatinib

chemoemtranscatherer arterial bolization

PLACEBO COMPARATOR

epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.

Drug: Apatinib

Interventions

TACEPROCEDURE

epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.

Also known as: chemoemtranscatherer arterial bolization
Apatinib combined with TACE
ApatinibDRUG

a molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor

Also known as: ai tan
Apatinib combined with TACEchemoemtranscatherer arterial bolization

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18-70 years old;
  • initial treatment diagnosed by histopathological or cytological examination BCLC Staging B/C Hepatocellular carcinoma of the liver ( HCC ) and at least one of the largest tumors in measurable lesions ≤15cm ;
  • Child-pugh liver function Rating: A level, B level;
  • BCLC Staging as B / C period;
  • before join in the group 1 weeks ECOG PS Rating: 0-1 score; estimated Lifetime ≥12 Week; Lab metrics meet the following criteria: ( 1 ) Blood routine check:
  • HB≥90 g/L;
  • ANC≥1.5x109/L;
  • PLT≥60x109/L; ( 2 ) Biochemical Examination:
  • <!-- -->
  • ALB≥29 g/L;
  • ALT and AST\<2.5\*ULN;
  • TBIL ≤ 2\*ULN;
  • Cr ≤ 1.5\*ULN;
  • women of childbearing age must be pregnancy tests before join in the group in 7 days;
  • Participants volunteered to join this study should sign informed consent, with good compliance and follow-up.

You may not qualify if:

  • Central hepatic artery / hepatic venous fistula in patients with hepatocellular carcinoma, diffuse liver cancer patients, with large vascular invasion of liver cancer patients (including portal vein tumor thrombus);
  • 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;
  • clinically symptomatic ascites that requires therapeutic celiac puncture or drainage with high blood pressure and cannot be reduced to normal range by anti hypertensive medications (systolic pressure \> 140 mmHg , diastolic pressure \>90 mmHg );
  • Suffering Ⅱ above-level myocardial ischemia or myocardial infarction, control of poor arrhythmia (including QTC inter-phase male ≥450 ms , female ≥470 ms );
  • Follow NYHA Standard Ⅲ \~ Ⅳ grade heart insufficiency or heart color Doppler ultrasonography: LVEF (left ventricular ejection fraction) \< 50% ;
  • There are various factors affecting oral medication (e.g.inability to swallow, chronic diarrhea and intestinal obstruction, which significantly affect drug use and absorption);
  • previous within 6 months there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: bleeding risk of esophageal varices, local active ulcer lesions, fecal occult blood ≥ ( ++ ) not in group; fecal occult blood (+ ), requiring gastroscopy;
  • before participating in this study There were abdominal fistula, gastrointestinal perforation or celiac abscess in the day;
  • Coagulation dysfunction ( INR \> 1.5 or prothrombin time ( PT ) \> ULN+4 seconds), with bleeding tendencies or undergoing thrombolysis or anticoagulant therapy;
  • patients who have undergone central nervous system metastasis or known brain metastases;
  • patients with objective evidence of the history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe lung impairment;
  • urine proteins are routinely shown ≥++ or confirmed 24 hour urine protein ration \> 1.0 g ;
  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

apatinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Zhi Guo, MD

    Tianjin Medical University Cancer Institute and Hospital

    STUDY CHAIR

Central Study Contacts

Zhi Guo, MD

CONTACT

18622221211cjr.guozhi@vip.163.com

Haipeng Yu, MD

CONTACT

13352070835jieruke@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2018

First Posted

January 12, 2018

Study Start

November 14, 2017

Primary Completion

October 1, 2018

Study Completion

April 1, 2019

Last Updated

January 12, 2018

Record last verified: 2017-11

Locations

CN(1)