Advanced hepatocellular carcinoma
Conditions
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients were explicitly diagnosed as HCC in terms of Clinical symptoms, signs and associated imaging, pathological examination, and positive AFP (refer to Hepatobiliary Clinical Practice in Oncology, Version 4.2017); 2. Aged 18 to 75 years old life expectancy >=12 weeks; 3. According to the solid tumor Response Assessment criteria (RECIST), there is at least one tumor lesion (without local treatment), and the target lesion has not received local treatment; 4. The lesions size>5x5x5mm; 5. Patients who have received local treatment, such as surgery, radiofrequency ablation, hepatic artery embolization, chemotherapy, radiotherapy, percutaneous puncture or cryoablation, but the target lesion volume has increased by more than 25% and the treatment has been discontinued for more than 4 weeks; 6. ECOG score =80x10^9/L; Hemoglobin >=100g/L; ANC >=1.5x10^9/L; International standard ratio (INR) =28g/L; Total bilirubin <=51.3 mol/L; Alanine transferase and aspartate transferase <=2 ULN; AST, ALT <=2.5 ULN (no evidence of liver metastasis); AST, ALT <=5.0 ULN (with evidence of liver metastasis); Creatinine <=1.5 ULN; Total bilirubin <=1.5 ULN; 10. Female subjects of childbearing age must undergo a serum pregnancy test within 3 days prior to the commencement of the study drug and be willing to use a highly effective, medically approved contraceptive method (e.g., intrauterine device, contraceptive pill or condom) during the study period and within 3 months after the last study drug administration; In the case of a male subject whose partner is a female of childbearing age, the subject should be surgically sterilized or agree to use an effective method of contraception during the study period and for a period of 3 months after administration of the last study; 11. I have given my consent and signed the informed consent, and am willing and able to comply with the planned visit, research treatment, laboratory examination and other test procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have received systematic treatment (including novel molecular targeted therapy) before enrollment; 2. Patients with acute infection or severe infection without control or high fever; 3. Those who are allergic or have serious adverse reactions to the drugs; 4. Patients with clinically significant active bleeding or with abnormal coagulation and clinically related bleeding risk; 5. Patients who underwent major surgery within 4 weeks before the first administration of the test drug; 6. Patients whose urine routine indicated that urinary protein =++, and confirmed 24-hour quantitative urinary protein > 1.0g; 7. Patients with complications from other serious diseases for which researchers were unable to assess efficacy; 8. Patients in critical condition requiring ICU admission; 9. Those who have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.). 10. Patients who have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 11. Patients with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness;Severe intellectual or cognitive impairment; 12. Pregnant or lactating women; 13. Patients considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;PFS;OS; | — |
Countries
China
Contacts
Public ContactChen Hao
Lanzhou University Second Hospital
Outcome results
None listed