Liver cancer
Conditions
Interventions
Case series:camrelizumab, apatinib mesylate and TACE
Sponsors
The First Affiliated Hospital of Suzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with HCC or cirrhosis confirmed by histology/cytology meet the clinical diagnostic criteria of the 2017 version of the standard for diagnosis and treatment of primary liver cancer; 2. Aged >= 18 years; 3. The stage of BCLC is stage C and stage B, which is not suitable for radical surgery and local treatment. 4. Had not received TACE or systemic anti-tumor therapy for HCC before the first administration; 5. At least one measurable lesion; 6. With sufficient organ and bone marrow functions, the laboratory examination value 7 days before the enrollment met the following requirements: 1) blood routine examination: ANC >= 1.5x10^9/L, PLT >= 50x10^9/L, HGB >= 9.0g/dL; 2) liver function: TBIL=28g/L, ALP=12 weeks; 10. Male patients with female reproductive age or female sexual partner of reproductive age should take effective contraceptive measures during the whole treatment period and 6 months after the last time of medication; 11. Signed written informed consent and family members who are able to comply with the protocol agree to participate in the clinical trial and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Previous histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 2. History of hepatic encephalopathy or liver transplantation; 3. Hydrothorax, ascites and pericardial effusion with clinical symptoms requiring drainage; 4. Metastasis of central system; 5. The main portal vein thrombus also involves the contralateral portal vein branch or the superior mesenteric vein. Inferior vena cava carcinoma thrombus; 6. Severe bleeding tendency or coagulation dysfunction; Received local treatment for liver cancer within 7.4 weeks; 8. Bleeding events of esophageal or gastric varices caused by portal hypertension within the previous 6 months, or any life-threatening bleeding events within 3 months; 9. Past 6 months of arteriovenous thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident or one-time ischemic attack, pulmonary embolism, deep vein thrombosis or any other history of severe thromboembolic events; 10. Uncontrolled hypertension, > 140mmHg systolic blood pressure or > 90mmHg diastolic blood pressure after treatment, history of hypertensive crisis or hypertensive encephalopathy; 11. Severe infection in the active stage or under clinical control; 12. Used immunosuppressive drugs within 4 weeks, excluding local glucocorticoids by nasal spray, inhalation or other means or systemic glucocorticoids with physiological doses; 13. Active autoimmune diseases requiring systemic treatment occurred within 2 years. Allowing the use of alternative therapies; 14. Received any previous anti-pd-1 antibody, pd-l1 antibody, anti-ctla-4 antibody or other immunotherapy. Previous targeted therapy against VEGF and/or VEGFR, RAF, MEK signaling pathways; 15. Patients infected with acute or chronic active hepatitis b or hepatitis c, HBV DNA > 2000IU/ml; HCV RNA > 103 copy /ml; 16. Congestive heart failure (grade ii-iv). A symptomatic or poorly controlled arrhythmia. 17. Pregnant or nursing female patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;AE; | — |
Countries
China
Contacts
Public ContactXiaoli Zhu
The First Affiliated Hospital of Suzhou University
Outcome results
None listed