hepatic carcinoma
Conditions
Interventions
Experimental group 1:Carrelizumab combined with apatinib mesylate treatment
Experimental group 2:Carilizumab combined with sorafenib toluenesulfonic acid treatment
Control group:Palliative chemotherapy or optimal supportive care
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Advanced hepatocellular carcinoma (HCC) confirmed by histopathology at the initial treatment; 2. BCLC stage B-C; 3. Initially unresectable or intolerant surgery, and no local treatment such as TACE or ablation or systemic anti-tumor therapy for HCC was received; 4. Associated with one or more local high risk factors (microvascular infiltration, portal vein cancer thrombogenesis, multiple nodules, non-capsular nodules, severe cirrhosis, alpha-fetoprotein (AFP) and its isomer levels); 5. ECOG score 0-1; 6. Expected survival >=3 months; 7. Child-pugh score 45 ml/min (Cockcroft - Gault formula); 11. Adequate tissue samples can be provided for pD-L1 or TMB tests or blood samples (1 week before treatment, and the immunoevaluation effect is conducted once every two months) for follow-up analysis; 12. Patients with potential fertility need to use a medically approved contraceptive method (such as iUDS, contraceptives or condoms) during and within one month of the end of the study treatment period; Serum or urine HCG examination within 72 hours before study inclusion must be negative and must be in non-lactation period. 13. Aged 18-80 years old; 14. Subjects volunteered to participate in this study and signed informed consent, with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously histologically/cytologically confirmed hepatocellular carcinoma containing fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. A history of hepatic encephalopathy or liver transplantation; 3. Previous history of allergy to experimental drugs: carillizumab, apatinib mesylate tablets, sorafenib toluene sulfonate tablets and any other ingredients; 4. Subjects with intractable pleural, peritoneal or pericardial effusion were not well controlled; 5. Previously received anti-PD-1 or PD-L1 or CTLA-4 or CAR-T immunotherapy; 6. Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK and other signaling pathways; 7. A history of interstitial lung disease (except for radiation pneumonia without hormone therapy) and non-infectious pneumonia; 8. Subject has any active autoimmune disease or history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or childhood asthma have been completely relieved and may be included as adults without any intervention; Asthma requiring medical intervention with bronchodilators will not be included); 9. Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone therapy for immunosuppression purposes (>10mg/ day prednisone or other therapeutic hormones) and continue to receive such therapy during the 2 weeks prior to enrollment; 10. Severe infection (CTCAE > level 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications requiring hospitalization, etc.; Baseline chest imaging indicated active pulmonary inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral and intravenous antibiotic therapy, except for prophylactic antibiotic use; 11. The subjects have had acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction and acute coronary syndrome within 1 month, and the clinical symptoms or diseases of cardiovascular diseases are not well controlled; 12. According to NYHA standard, ? ~ ? cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) 140mmHg or diastolic blood pressure > 90mmHg after treatment, history of hypertensive crisis or hypertensive encephalopathy; 14. Patients with definite gastrointestinal bleeding tendency include: locally active ulcer foci and fecal occult blood {(++) not included}; A history of black stool and hematemesis within 2 months; 15. Abnormal coagulation function (INR>1.5 APTT>1.5 ULN), with bleeding tendency; 16. A wound or fracture that has not been healed for a long time; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 17. Subjects with congenital or acquired immune deficiency (such as HIV infection) or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value); 18. Persons with a history of abuse of psychotropic substances and who are unable to quit or have a mental disorder; 19. Patients with concomitant diseases that, according to th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;Disease control rate;objective remission rate;quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactWang Yi
Qilu Hospital of Shandong University
Outcome results
None listed