HCC
Conditions
Interventions
PD-1/PD-L1 inhibitors + bevacizumab/lenvatinib + sartans group:None
PD-1/PD-L1 inhibitors + bevacizumab/lenvatinib + non-sartan antihypertensive drugs group:None
Sponsors
Taizhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, advanced HCC (BCLC stage C or unresectable stage B) confirmed by histological or cytological pathology according to the 8th edition of liver cancer staging; 2. Never received systemic treatment before (naive) or failed first-line targeted therapy (second-line); 3. According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there must be at least one measurable lesion as the target lesion, and the measurable lesion should not have received local treatment such as radiotherapy; 4. Child-Pugh liver function score A or B (=12 weeks; 6. Laboratory test values within one week before treatment meet the following conditions: (1) Blood routine: white blood cell count >= 3.0×10^9/L; neutrophil count >= 1.5×10^9/L; platelet >= 100×10^9/L; hemoglobin content >= 9.0g/dL; (2) Liver function: for subjects without liver metastasis, aspartate aminotransferase = 50 mL/minute. 7. Previously diagnosed with hypertension, or blood pressure monitored for three consecutive days after admission is higher than 130/80mmHg.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of severe bleeding disorders before hospitalization; those with any signs or history of bleeding diathesis; those who experienced any bleeding or hemorrhagic events = CTCAE grade 3 within 4 weeks before randomization; those with unhealed wounds, ulcers or fractures. 2. Patients who have received any T-cell co-stimulation or immune checkpoint therapy in the past. 3. Patients with active, known or suspected autoimmune diseases; those who are HBsAg positive with HBV DNA copy number greater than the upper limit of normal in the laboratory of the research center (1000 copies/ml or 500 IU/ml), or HCV positive (HCV RNA or HCV Ab test indicates acute or chronic infection); those with a known history of HIV positivity or known acquired immune deficiency syndrome. 4. Patients with severe cardiovascular diseases (coronary heart disease or congestive heart failure, LVEF < 50% or NYHA III-IV grade); those with arterial thromboembolic disease (myocardial infarction, cerebrovascular accident); those with uncontrolled hypertension, hypertensive crisis or hypertensive encephalopathy. 5. Patients with autoimmune diseases or long-term use of immunosuppressants. 6. Patients with known hypersensitivity to bevacizumab or other similar biosimilars. 7. Patients with a history of allergy to ARB drugs. 8. Patients with a history of hypertension and poor response to valsartan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival,OS; | — |
Countries
China
Contacts
Public ContactYin Yuan
Taizhou People's Hospital
Outcome results
None listed