liver cancer
Conditions
Interventions
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University school of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The expected survival time of primary liver cancer patients aged 18-75 years, with expected survival time of at least 6 months; 2. Patients with stage II-IIIA hepatocellular carcinoma who are diagnosed as primary liver cancer and cannot be resected in accordance with [2019 edition of Guidelines for the diagnosis and Treatment of primary liver cancer by the Ministry of Health of China] are patients with previous first-line resistance to sorafenib or lenfatinib 3. No extrahepatic metastasis; 4. Child-pugh grade A or B of liver function;ECOG physical Condition score 1; 5. The laboratory test values within 7 days before enrollment meet the following conditions: 1) Absolute Neutrophil count (ANC)>=1.5x 10^9/L; 2) Platelet count (PLT)=100×109/L; 3) Hemoglobin content (hemoglobin.HGB)>=9.0g/dL; 4) Total bilirubin (TBIL)=28g/L; 7) Alkaline phosphatase (ALP) =50mL/min (Cockcroft-Gault formula); 9) Urine routine results showed urinary protein =2+ in routine urine tests at baseline, 24-hour urine collection and 24-hour urine protein quantification <1g should be performed. 10) International standard ratio (INR) or activated partial thrombin time (APTT) <=1.5 ULN; 6. For female patients of childbearing age or male patients whose sexual partners are female of childbearing age, effective contraceptive measures shall be taken during the whole treatment period and 6 months after the last medication; 7. The patient and/or family members agree to participate in the clinical trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Irreversible coagulation dysfunction and obvious blood abnormalities, with obvious bleeding tendency; (2) Intractable massive ascites; (3) Associated with active infection, especially inflammation of the bile duct system; (4) Serious diseases of the heart, lungs, kidney, brain and other important organs; (5) pregnant or lactating mothers; (6) Combined with HIV infected patients; (7) has had an active autoimmune disease requiring systemic treatment in the past 2 years; (8) Diffuse liver cancer; Hepatobiliary cell carcinoma, mixed cell carcinoma and fibre-lamellar cell carcinoma are known; (9) prior (within 5 years) or concurrent history of other uncured malignancies, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix; (10) with myocardial ischemia and myocardial infarction II class above, poor control of cardiac arrhythmias (including QTc interphase male 450, female 470 ms or ms or higher); (11) Patients with a history of gastrointestinal bleeding or a clear tendency of gastrointestinal bleeding in the past 6 months, such as: esophageal varices with bleeding risk, locally active ulcer lesions, fecal occult blood >= (++) cannot be included in the group;If fecal occult blood (+) is required, gastroscopy is required; (12) Patients who are about to undergo liver transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival; | — |
Countries
China
Contacts
Public ContactDan Cui
Renji Hospital affiliated to Shanghai Jiao Tong University school of Medicine
Outcome results
None listed