Hepatocellular carcinoma
Conditions
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. HCC confirmed by histopathology at the first treatment; 2. BCLC is divided into B-C phase; 3. The operation was not possible, TACE or systemic anti-tumor treatment for HCC was not accepted before the first administration; 4. The following conditions can be included in the group: portal vein tumor thrombus formation (PVTT, VP1, VP2, VP3), multiple nodules, incomplete capsule, large mass type, severe cirrhosis, extrahepatic metastasis, etc; 5. ECoG score is 0-1; 6. The expected life span is >= 3 months; 7. At least one measurable lesion (according to RECIST 1.1 standard, the CT scan length of tumor lesions is >= 10 mm, and the CT scan short diameter of lymph node lesions is >= 15mm); 8. Child Pugh score =1.5 x10^9/L 2) PLT>=80 x 10^9/L (2) Biochemical examination shall meet the following standards: 1) TBIL < 1.5 x ULN 2) ALT and AST were less than 2.5 x ulin, but for liver metastasis patients < 5 x ULN; 3) The serum Cr <= 1.25 x ULN or the clearance rate of endogenous creatinine was more than 45 ml / min (Cockcroft-Gault formula); 13. Patients with potential fertility need to adopt a medically approved contraceptive measure (such as IUD, contraceptive or condom) during the study treatment period and 1 month after the end of the study treatment period; and the HCG examination of serum or urine must be negative and must be non lactation within 72 hours before the study is put into the group; 14. Aged 18-80 years; 15. Subjects voluntarily join the study and sign informed consent form, which is in good compliance with the follow-up.
Exclusion criteria
Exclusion criteria: 1. The components of the former fibroplate-based HCC, sarcoma like hepatocarcinoma and cholangiocarcinoma were confirmed by histology / cytology; 2. Have a history of hepatic encephalopathy or a history of liver transplantation; 3. Previous allergic history to any component of the test drug: carrizumab and apatinib mesylate tablets; 4. The control of refractory pleural effusion, abdominal cavity or pericardial effusion was not good; 5. The portal vein main cancer thrombus involves the opposite portal vein branch at the same time, or the superior mesenteric vein and the inferior vena cava tumor thrombus (PVTT, VP4); 6. There are history of interstitial lung disease (except radiation pneumonia without hormone therapy), and non infectious pneumonia; 7. The subjects had any active autoimmune disease or had a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects suffering from vitiligo or asthma in childhood have been completely relieved, and no need for any intervention in adulthood can be included; asthma that subjects need bronchodilators to intervene in medicine can not be included); 8. The subjects were using immunosuppressant, or systemic or absorbable local hormone to achieve immunosuppressive purpose (dose > 10mg/ day prednisone or other therapeutic hormone), and was still in use within 2 weeks before entering the group; 9. Severe infection (CTCAE > Level 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complication requiring hospitalization, etc.; baseline chest imaging examination indicated active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug or antibiotic treatment by oral and intravenous use, except for preventive use of anti infection The condition of the hormone; 10. The subjects had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the cardiovascular clinical symptoms or diseases were not well controlled; 11. According to NYHA standard, the patients with grade III-IV cardiac dysfunction or the left ventricular ejection fraction (LVEF) less than 50% were indicated by color doppler echocardiography; 12. The uncontrolled hypertension, after treatment, systolic pressure > 140mmHg or diastolic pressure > 90mmHg, hypertension crisis or hypertension encephalopathy history; 13. The bleeding of esophageal or gastroesophageal varices caused by portal hypertension occurred in the past 6 months, or any life-threatening bleeding event occurred in March; 14. Patients with definite gastrointestinal bleeding tendency include the following conditions: local active ulcer lesions, and stool latent blood (+ +) can not be included in the group; those with black stool and hematemesis within 2 months; 15. The coagulation function was abnormal (INR > 1.5; APTT > 1.5 ULN), and the bleeding tendency was found; 16. Long term uncured wound or fracture; received major surgical operation or severe traumatic injury, fracture or ulcer within 4 weeks; 17. The subjects had congenital or acquired immune function defects (such as HIV infected persons); 18. Acute or chronic active hepatitis B or hepatitis C infection (HBV DNA > 2000iu/ml; HCV RNA > 103 copies / ml); 19. Patients with m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival time, PFS;Overall survival time, OS;Disease control rate, DCR;Duration of overall response, DOR;Quality of life, Qol; | — |
Countries
China
Contacts
Public ContactCui Yi
Shandong Provincial Hospital
Outcome results
None listed