Hepatocellular carcinoma
Conditions
Interventions
experimental group:Apatinib + Carrelizumab + TACE
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years old; 2. Strictly meet the clinical diagnostic criteria of "Primary Liver Cancer Diagnosis and Treatment Standards" (2011 edition) or HCC patients diagnosed with HCC for the first time by histopathology or cytology or HCC patients with recurrence/metastasis more than one year after hepatectomy (not received Systemic treatment/local treatment), and at least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the spiral CT scan of the measurable lesion >=10mm or the short diameter of enlarged lymph nodes >=15mm); the largest tumor =12 weeks; 9. The main organs function is normal meet the following standards: (1) Routine blood examination: HB>=60 g/L; ANC>=1.0x10^9/L; PLT>=60x10^9/L; (2) Biochemical inspection: ALT and AST<5 ULN; TBIL <=1.5 ULN; Creatinine <=1.5 ULN; (In the Child-Pugh rating, only one of albumin and bilirubin can be scored as 2 points); 10. Women of childbearing age must have a pregnancy test within 7 days before enrollment; 11. Meet the TACE indications; 12. The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has an immunodeficiency disease or medical history, or a history of organ transplantation; 2. Have received any local treatment/systemic treatment within one year before participating in the study; 3. The patient has hepatobiliary cell carcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma; previously (within 5 years) or at the same time suffering from other uncured malignancies, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 4. Patients who are preparing for liver transplantation (except those who have undergone liver transplantation in the past); 5. The patient has ascites with clinical symptoms, that is, requires therapeutic abdominal puncture or drainage, or Child-Pugh score> 2; 6. Patients who have hypertension and cannot fall within the normal range after treatment with antihypertensive drugs (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg); 7. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval male >=450 ms, female >=470 ms); 8. There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the administration and absorption of drugs); 9. A history of gastrointestinal bleeding in the past 6 months or a clear gastrointestinal bleeding tendency, such as: esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood >=(++) cannot be included in the group; If stool occult blood (+), gastroscopy is required; 10. Had an abdominal fistula, gastrointestinal perforation or abdominal abscess in the 28 days before participating in this study; 11. Abnormal coagulation function, bleeding tendency or receiving thrombolysis or anticoagulation therapy; 12. Patients with central nervous system metastases or known active brain metastases; 13. The patient has objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 14. Urine routine test showed urine protein >=++ or confirmed 24-hour urine protein quantitative >1.0 g; 15. In the 7 days before participating in the study, the patient had received strong CYP3A4 inhibitors (including erythromycin, clarithromycin, josamycin, acetylspiramycin, ritonavir, itraconazole, ketoconazole) , Diltiazem, nicardipine, verapamil and mebefradil, etc.), or received strong CYP3A4 inducer treatment within 12 days before participating in the study; 16. Pregnant or breast-feeding women; fertile patients who are unwilling or unable to take effective contraceptive measures; 17. Have a mental illness or a history of psychotropic drug abuse; 18. Patients with bone metastases who have received palliative radiotherapy (radiotherapy area> 5% bone marrow area) within 4 weeks before participating in the study; 19. Combined HIV-infected patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;OS;DCR; | — |
Countries
China
Contacts
Public ContactXuehao Wang
Jiangsu Provincial People's Hospital
Outcome results
None listed