primary liver cancer
Conditions
Interventions
treatment group:Stereotactic body radiotherapy (SBRT) combined with camrelizumab and apatinib
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Primary liver cancer that strictly complies with the clinical diagnostic criteria of the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (2019 Edition) or is confirmed by histopathological or cytological examination Patients with at least one measurable lesion (according to the RECIST1.1 standard, the spiral CT scan of the measurable lesion requires that the long diameter of the measurable lesion >=10mm or the short diameter of the malignant lymph node >=15mm, see Annex 4 for the RECIST 1.1 version); 3. Patients with locally advanced or metastatic primary liver cancer that cannot be cured by systemic treatment; 4. Chlid-Pugh score =12 weeks; 8. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be less than 2000 IU/mL (if the research center only has copy/mL testing units, It must be less than 12500 copy/mL), and have received anti-HBV treatment (based on local standard treatment, such as entecavir) for at least 14 days before the start of the study treatment and are willing to receive antiviral treatment throughout the study period; hepatitis C virus (HCV) 1) Ribonucleic acid (RNA)-positive patients must receive antiviral treatment in accordance with local standard treatment guidelines and liver function should be within the CTCAE level 1 elevation; 9. The main organ function is normal and meets the following standards: (1) Routine blood examination standards need to meet: (No blood transfusion within 14 days): Hemoglobin (HB) >=100g/L; White blood cell count (WBC) >=3x10^9/L; Absolute neutrophil count (ANC) >=1.5x10^9/L; Platelet (PLT) >=80x10^9/L; (2) Biochemical examination must meet the following standards: Bilirubin (BIL) <1.5 ULN; Gu C Transaminase (ALT) and aspartate transaminase AST<5 ULN; Serum creatinine (Cr)<=1.5 ULN; 10. Women of childbearing age must have a negative result of pregnancy test (serum) or urine HCG test within 7 days before enrollment, and are willing to test Use appropriate methods of contraception during the period and 8 weeks after the last administration of the test drug; for men, surgical sterilization should be performed, or agree to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the test drug; 11. Subjects voluntarily join the book Study, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Women during pregnancy or breastfeeding; 2. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation or other malignant tumors (except cured skin basal cell carcinoma and cervical carcinoma in situ); 3. Patients with impaired consciousness or inability Cooperate with treatment and patients with mental illness; 4. Patients who have participated in other clinical trials in the past three months; 5. Have received treatment with apatinib, carrelizumab or other PD-1/PD-L1 inhibitors in the past; 6. Received major surgery or chemotherapy, radiotherapy or other systemic treatments for the lesion within 1 month before enrollment; 7. Use immunosuppressant or systemic hormone therapy within 14 days before enrollment to achieve the purpose of immunosuppression (Dosage>10mg/day prednisone or other curative hormones); 8. Liver function is classified as Child-Pugh C, which cannot be improved by liver protection treatment. 9. There was bleeding from varicose veins of the esophagus (fundus of stomach) within 1 month before treatment. 10. Uncorrectable coagulation dysfunction and severe blood abnormalities, with severe bleeding tendency. Platelet count 140 mmHg, diastolic blood pressure> 90 mmHg); 16. Past severe cardiovascular diseases, including but Not limited to the following diseases: Myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (including QTc interval >=450 ms for males and >=470 ms for females); according to NYHA standards, grade III to IV cardiac insufficiency, or heart Color Doppler ultrasound examination showed that the left ventricular ejection fraction (LVEF) was less than 50%; 17. Patients with positive urine protein (2+ urine protein test or above, or 24-hour urine protein quantitative> 1.0g); 18. Unable to swallow tablets or absorb Adverse syndrome or any condition that affects gastrointestinal absorption; 19. According to the judgment of the investigator, there are other patients with other serious harm to the safety of the patient or patients with concomitant diseases that affect the completion of the study; 20. With radiotherapy, targeted therapy and immunotherapy, etc. Patients with contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective remission rate;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival;Disease control rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactJuhui Chen
Fujian Cancer Hospital
Outcome results
None listed