Hepatocellular carcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histopathologically confirmed hepatocellular carcinoma; 2. Patients who have relapsed after surgery; 3. The patient is unsuitable or unwilling to undergo surgery again; 4. No extrahepatic metastasis; 5. Child-Pugh liver function rating: A grade or better grade B (= 7 points) 6. Age 18 years old or above, male or female; 7. ECOG PS: 0-2 points; 8. The expected survival period is greater than or equal to 12 weeks; 9. The main organs function normally, that is, the following criteria are met: (1) Blood routine examination: (no blood transfusion within 14 days before screening, no use of G-CSF, no use of drugs to correct) HB=90 g/L; ANC=1.5× 109/L; PLT=75×10^9/L; (2) Biochemical examination: (ALB not input within 14 days) ALT and AST<5×ULN; TBIL =2×ULN; creatinine =1.5×ULN; 10. Women of childbearing age should be carried out in the group of 7 days before the pregnancy test (serum or urine), and the results were negative, and willing to during the test and the last to test drugs after 8 weeks, using appropriate methods of contraception. In the case of men, surgical sterilization should be carried out or appropriate methods of contraception should be agreed to during the trial and 8 weeks after the last administration of the experimental drugs; 11. Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.
Exclusion criteria
Exclusion criteria: 1. Hepatic cholangiocarcinoma and mixed-cell carcinoma and fibrolamellar cell carcinoma have been diagnosed; in the past (within 5 years) or other untreated malignant tumors, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 2. Patients who are ready for liver transplantation (except for patients who have undergone liver transplantation); 3. Difficult to control ascites, hepatic encephalopathy or esophageal varices bleeding; 4. People with high blood pressure who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 5. myocardial ischemia with above grade II or myocardial infarction, arrhythmia 6. A variety of factors affecting oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, significantly affecting the use and absorption of drugs); 7. In the past 6 months, there is a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding, such as: esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood = (++) can not be included; 8. Have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 9. Patients with central nervous system metastases or known brain metastases have developed; 10. Urine routinely showed urinary protein = ++ or confirmed 24-hour urine protein quantitation > 1.0 g; 11. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 12. HIV infected patients; 13. Patients with a history of psychotropic substance abuse who cannot be cured or who have mental disorders; 14. Patients who have participated in clinical trials of other drugs within 4 weeks; 15. The investigator determines other conditions that may affect the conduct of the clinical study and the outcome of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Objective remission rate;Quality of Life; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Chongqing Medical University