hepatocellular carcinoma
Conditions
Interventions
experimental group:Camrelizumab+apatinib
Sponsors
Shandong Cancer Research Institute
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, both male and female; 2. The initial diagnosis of HCC by histology or cytology is in accordance with the 2019 edition of the National Health Commission of the People's Republic of China for the diagnosis and treatment of primary liver cancer, and meets the clinical diagnostic criteria for liver cancer; 3. Patients with stage ?b oligometastatic hepatocellular carcinoma with 1 to 5 distant metastases; 4. Liver function Child-Pugh A, B stage; 5. At least one area is suitable for receiving hypofractionated radiotherapy (including primary lesions), with measurable lesions that meet the RECIST v1.1 standard for evaluation; there may be stable brain metastases before enrollment but not included in the statistics of measurable lesions Within; bone metastases without soft tissue formation can be included in the group but not as measurable lesions, if there is soft tissue formation and meet the measurable conditions, it is considered as a measurable lesion; 6. ECOG score: 01; 7. The expected survival period is greater than 3 months; 8. The functions of vital organs meet the following requirements (not including the use of any blood components and cell growth factors within 14 days): Routine blood examination standards must meet (no blood transfusion and blood products within 14 days): The absolute count of neutrophils >= 1.5 x 10^9/L; Platelet >= 100 x 10^9/L; Hemoglobin >= 9g/dL; Serum albumin >= 3g/dL; Thyroid-stimulating hormone (TSH) = 60 mL/min. 9. Non-surgical sterilization or female patients of childbearing age need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment and within 3 months after the end of the study treatment; Female patients of childbearing age who undergo surgical sterilization must be negative in serum or urine HCG within 7 days before enrollment in the study; and must be non-lactating; male patients of childbearing age who are not surgically sterilized must agree with their spouse during the study treatment period and the study Use a medically approved contraceptive method within 3 months after the end of the treatment period. 10. Subjects voluntarily joined the study, signed a written informed consent form before joining the group, had good compliance, and cooperated with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, reduced thyroid function; subjects suffering from vitiligo or asthma in childhood has completely resolved, and no intervention after adults can be included; subjects requiring bronchodilators for medical intervention can not be included in asthma); 2. Subjects are using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose>10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 3. Severe allergic reaction to other monoclonal antibodies; 4. The subject has central nervous system metastases with clinical symptoms (such as brain edema, need for hormonal intervention, or brain metastasis progression). Patients who have previously received brain or meningeal metastasis therapy, such as clinical stability (MRI) have been maintained for at least 1 month, and have stopped systemic hormone therapy (dose>10mg/day prednisone or other curative hormones) for more than 2 weeks can be included 5. Cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Heart failure above NYHA level 2; (2) Unstable angina; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular with clinical significance Or ventricular arrhythmia requires treatment or intervention; (5) QTc>450ms (male); QTc>470ms (female); 6. Abnormal coagulation function (INR>1.5 or PT>16s), bleeding tendency or receiving thrombolysis or anticoagulation therapy; 7. Subjects who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, after the completion of the treatment (last medication), and less than 4 weeks before the study medication (or 5 drug half-lives, whichever is longer)); patients whose adverse events (except hair loss) caused by previous treatment have not recovered to 38.5 degrees during the screening period and before the first administration; 12. Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 13. Subjects with congenital or acquired immune deficiencies (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 test value exceeds the upper limit of normal value); 14. Those who have used other drugs in clinical trials or similar treatment drugs within 4 weeks before the first use of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;6 months progression-free survival;ORR;DCR;OS; | — |
Countries
China
Contacts
Public ContactYue Jinbo
Shandong Cancer Research Institute
Outcome results
None listed