liver cancer
Conditions
Interventions
one:Prophylactic TACE was given 4-8 weeks after TACE, and Camrelizumab was given 2-8 weeks after TACE, with a fixed dose of 200mg, by intravenous drip, and each infusion was not less than 30 min and n
two:Preventive TACE was given from 4 to 8 weeks after operation.
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years old 2. Subjects diagnosed as hepatocellular carcinoma by histopathology 3.ECOG 0-1 4.Child-Pugh score A level 5. Have undergone radical resection. 6. factors with high recurrence risk of hepatocellular carcinoma after resection ? multiple tumors ? tumor length > 5cm ?Edmondson ?~? grade ? invasion of microvessels or great vessels ? lymph node metastasis ? ?AFP and/or DCP are persistently abnormal, and any one of them is considered as high recurrence risk. 7. No systematic treatment or local treatment was received after radical resection. 8. No extrahepatic metastasis 9. Subjects must be able to understand and be willing to sign written informed consent. 10. At the time of signing the informed consent form (ICF), all acute toxic effects of any previous treatment have subsided to NCI-CTCAE v4.0 1 or lower, except alopecia. 11. Evaluate sufficient bone marrow, liver and liver function according to the following laboratory requirements: total bilirubin = 1.5 times the upper limit of normal (ULN), except for Gilbert syndrome subjects with bilirubin < 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN. Alkaline phosphatase limit = 5 x ULN). Serum creatinine < 2 x ULN. Hematological parameters are as follows: platelet count = 75× 109/L; . Hemoglobin (HB) = 9g/dl, and absolute neutrophil count (ANC) = 1.5× 109/L. (Can't meet the requirements by using granulocyte colony stimulating factor or blood transfusion) 12. Fertile women must undergo a negative serum or urine pregnancy test (minimum sensitivity is 24 IU/L or equivalent HCG) within 72 hours before the start of treatment. Postmenopausal women (defined as at least one year without menstruation) and surgically sterilized women do not need to undergo a pregnancy test. 13. Fertile subjects (male and female) must agree to use adequate contraceptive measures from the time of signing ICF until at least 3 months after the last dose of study drug. The definition of proper contraception will be based on the judgment of the principal investigator or designated colleague. 14. Patients with a history of hepatitis B and hepatitis C can be enrolled, but patients with hepatitis B must start antiviral treatment before starting research treatment.
Exclusion criteria
Exclusion criteria: 1. Hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma. 2. Previous or complicated cancer within 5 years before the start of treatment, except cured cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invading lamina propria)]. 3. Study the history of allergy or intolerance of pharmaceutical ingredients. 4. There is hepatic encephalopathy when entering the group. 5. Have uncontrollable moderate to severe ascites. 6. Subjects with active central nervous system metastasis were excluded. If the central nervous system metastasis is treated, and the subject is at the nerve baseline at least 2 weeks before entering the group, it will meet the conditions, but brain MRI is needed before entering the group. Subjects must stop taking corticosteroids or take a stable or reduced dose of = daily prednisolone (or equivalent dose). 7. Subjects with active, known or suspected autoimmune diseases. Subjects with vitiligo, type I diabetes, residual hypothyroidism caused by autoimmune thyroiditis that only needs hormone replacement, or diseases that are not expected to recur without external triggers are allowed to participate. 8. Subjects who need systemic treatment with corticosteroids (> 14 mg daily prednisone equivalent) or other immunosuppressive drugs within 10 days after enrollment. In the absence of active autoimmune diseases, inhaled or topical steroids are allowed, and the dose of adrenal replacement steroids is > 10 mg daily prednisolone equivalent. 9. Known human immunodeficiency virus (HIV) infection history or acquired immunodeficiency syndrome (AIDS). 10. Drug abuse, medical, psychological or social conditions that may interfere with patients' participation in research or evaluation of research results. 11. The history or complications of interstitial lung disease with any grade or severe impairment of lung function. 12. The unresolved toxicity is higher than CTCAE grade 1, which is attributed to any previous treatment/procedure except alopecia. 13. Any disease or medical condition that is unstable or may endanger the safety of patients and their compliance. 14. Take hormone therapy during the study period or within 2 weeks after the first study. 15. During the first study treatment or within 4 weeks, research drug treatment was conducted outside this trial. Pregnant or lactating women. 16. According to the researcher's judgment, the subject has other factors that may cause him to be forced to terminate the study halfway, such as other serious diseases (including mental illness) that require combined treatment, family or social factors, which may affect the safety of the subject or the collection of research data. Other factors that the researcher thinks are not suitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse free survival;Overall survival,OS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time To Progression;Adverse Events;Serious adverse events; | — |
Countries
China
Contacts
Public ContactGao Jie
Peking University People's Hospital
Outcome results
None listed