Liver cancer
Conditions
Interventions
Experimental group:Probiotics + Apatinib + TACE
Control group:Apatinib + TACE
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old; 2. Patients with unresectable HCC who strictly conform to the clinical diagnostic criteria of the Standards for Diagnosis and Treatment of Primary Hepatocellular Carcinoma (2011 edition) or whose recurrence/metastasis has been confirmed by histopathology or cytology cannot receive palliative surgery or radiotherapy, and have at least one measurable lesion (according to the requirements of RECIST 1.1, which can measure the length of the lesion by spiral CT scan more than 10 mm or enlarged lymph nodes). The shortest diameter of the nodule (> 15 mm) and the largest tumor ( 90 g/L; B) ANC (>1.5*109/L); C) PLT (> 60 *109/L); (2) Biochemical examination: A) ALB (> 29 g/L); B) ALT and AST < 2.5?ULN; C) TBIL < 2?ULN; D) Creatinine < 1.5?ULN; (Only one of the two indicators in Child-Pugh rating is 2 points for albumin and bilirubin) 9. Pregnancy tests should be carried out within 7 days before admission for women of childbearing age. 10. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Received any local treatment except TACE (including but not limited to surgery, radiotherapy, hepatic artery embolism, hepatic artery perfusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) within four weeks prior to the study. 2. Hepatobiliary and mixed cell carcinomas and fiberboard cell carcinomas are known; in the past (within 5 years) or with other incurable malignant tumors, except for cured skin basal cell carcinomas and cervical carcinoma in situ; 3. Patients preparing for liver transplantation (excluding those who have previously undergone liver transplantation); 4. Ascites with clinical symptoms, i.e. therapeutic abdominal puncture or drainage, or Child-Pugh score > 2; 5. Patients with hypertension whose systolic blood pressure is > 140 mmHg and diastolic blood pressure is > 90 mmHg can not be reduced to normal range by antihypertensive drugs. 6. Patients with myocardial ischemia or myocardial infarction above grade II and arrhythmia with poor control (including male (>450 ms) and female (>470 ms) during the QTc interval; 7. According to NYHA standard, grade III-IV cardiac insufficiency or color Doppler echocardiography: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT) > ULN + 4 seconds), prone to bleeding or undergoing thrombolysis or anticoagulation therapy; 12. Patients with central nervous system metastasis or known brain metastasis; 13. Patients with past and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc. 14. Urinary routine showed that urinary protein (++) or confirmed 24-hour urinary protein quantification (>1.0 g); 15. The patients received potent CYP3A4 inhibitors within 7 days prior to the study, or potent CYP3A4 inducers within 12 days prior to the study. 16. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures; 17. Have a history of mental illness or psychotropic drug abuse; 18. Patients with bone metastases received palliative radiotherapy (radiotherapy area > 5% bone marrow area) within four weeks prior to the study; 19. Joint HIV infection patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TTP; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;PFS;ORR;ORR; | — |
Countries
China
Contacts
Public ContactZhang Bo
Shandong Cancer Hospital
Outcome results
None listed