Hepatocellular carcinoma(HCC)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old; 2. HCC diagnosed by histology/cytology or clinically meets the clinical diagnostic criteria of the 2019 version of the diagnosis and treatment of primary liver cancer; 3. CNLC Ib-CNLC IIIb hepatocellular carcinoma patients who are not suitable for surgery; 4. Did not receive systemic anti-tumor therapy within half a year before enrollment; 5. There is at least one measurable lesion (mRECIST); 6. Child-Pugh score = 9 points; 7. ECOG physical status score 0-2 points; 8. The expected survival period is =12 weeks; 9. It has sufficient organ and bone marrow functions, and the laboratory examination values 7 days before entry meet the following requirements: 1) Blood routine: ANC>=1.5x10^9/L, PLT>=50x10^9/L, HGB>=9.0g/dL; 2) Liver function: TBIL<=2 ULN, ALT and AST<=5 ULN 10. Females of childbearing age or male patients whose sexual partners are females of childbearing age should take effective contraceptive measures during the entire treatment period and within 6 months after the last medication; 11. Sign a written informed consent form, and can comply with the provisions of the plan and the family members agree to join the clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There is a history of other tumors within 5 years; 2. Previously diagnosed by histology/cytology with fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and other components; 3. Patients with large amounts of cancerous ascites and brain metastases; 4. The main portal vein tumor thrombus involves the contralateral portal vein branch at the same time; 5. Local treatments including ablation, TACE, and radiotherapy were performed within two months before enrollment; 6. Liver cancer patients who plan to undergo liver transplantation or surgical resection; 7. Severe infections in active phase or poor clinical control; 8. There are grade II heart failure, myocardial ischemia and uncontrollable arrhythmia; 9. Esophageal or gastric varices bleeding caused by portal hypertension occurred within the past 6 months, or any life-threatening bleeding event occurred within 3 months; 10. Diseases that affect the efficacy of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.; 11. Subjects who have had serious adverse reactions to iodinated contrast media; 12. Pregnant and lactating women; 13. Subjects considered by the investigator to be unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ProgressionFreeSurvival; | — |
Secondary
| Measure | Time frame |
|---|---|
| OverallSurvival;Objective response rate;Disease Control Rate;Drug safety; | — |
Countries
China
Contacts
The First Affiliated Hospital of Bengbu Medical College