Status:
UNKNOWN
Study of Apatinib Combined With TACE in Advance Hepatocellular Carcinoma
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
the purpose of this study is to evaluate the efficacy and safety of aptinib in patients with advanced HCC
Detailed Description
HCC The is a common malignancy in the world, especially in China. Advanced HCC treatment is difficult and the prognosis is poor, which is still a great challenge and threat to the medical profession. ...
Eligibility Criteria
Inclusion
- 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:
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- 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.
Exclusion
- 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;
- Union HIV infected patients;
Key Trial Info
Start Date :
November 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT03398122
Start Date
November 14 2017
End Date
April 1 2019
Last Update
January 12 2018
Active Locations (1)
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1
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060