Hepatocellular carcinoma
Conditions
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. HCC confirmed by histopathology at the first treatment; 2. BCLC stage B-C; 3. Before the first administration, he was treated with hepatocarcinoma resection in January, and he did not receive TACE or systemic anti-tumor treatment for HCC; 4. There is a high risk of recurrence (microvascular infiltration, portal vein thrombosis, multiple nodule, nodule without capsule, severe cirrhosis, AFP and its isomer level); 5. ECoG score is 0-1; 6. The expected life span is >= 3 months; 7. Child Pugh score = 1.5 x 10^9/L 2) PLT >= 80 x 10^9/L (2) Biochemical examination shall meet the following standards: 1)TBIL 45 ml / min (Cockcroft Gault formula); 11. Sufficient tissue standard for PD-L1 or TMB and other tests or blood samples (1 week before treatment, immune evaluation once every two months) can be provided for subsequent analysis; 12. 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; 13. 18 to 80 years old; 14. 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: camrelizumab 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 at the same time; 6. We have received targeted treatment of anti VEGF and / or VEGFR, RAF, MEK and other signaling pathways; 7. There are history of interstitial lung disease (except radiation pneumonia without hormone therapy), and non infectious pneumonia; 8. 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 when adulthood can be included; asthma that subjects need bronchodilators to intervene in medicine can not be included); 9. The subjects were using immunosuppressant, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10mg / day prednisone or other therapeutic hormone), and was still in use within 2 weeks before entering the group; 10. 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 antibiotic; 11. 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; 12. According to NYHA standard, the patients with grade III-IV cardiac dysfunction or the left ventricular ejection fraction (LVEF) less than 50% indicated by color doppler echocardiography; 13. The uncontrolled hypertension, after treatment, systolic pressure > 140mmHg or diastolic pressure > 90mmHg, hypertension crisis or hypertension encephalopathy history; 14. Patients with definite gastrointestinal bleeding tendency include the following conditions: local active ulcer lesions, and feces latent blood (+ +) can not be included in the group; those with black feces 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. Subjects with congenital or acquired immune function defects (such as HIV infected persons), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; hepatitis C reference: HCV titer or RNA detection value exceeds the upper limit of normal value); 18. Patients with me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-Year recurrence free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-Year recurrence free survival;Recurrence free survival;1Year overall survival;Overall survival;Quality of life; | — |
Countries
China
Contacts
Public ContactLu Jun
Shandong Provincial Hospital
Outcome results
None listed