hepatocellular carcinoma
Conditions
Interventions
Test group:The subject received AK104 IV: 10 mg/kg every 21 days ((3-week regimen, Q3W)
Oral administration of lenvatinib: 8 mg (2 4 mg capsules) once daily for patients weighing 60 kg
12 mg (3 4 mg capsules) once daily for patients weighing >=60 kg. Continue treatment until disease progression or intolerable toxic side effects occur.
Sponsors
the Second Affiliated Hospital of Army Medical University, PLA ,China
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age is 18~85 years old, gender is not limited; 2. hepatocellular carcinoma diagnosed pathologically; 3. Recurrence after previous surgical resection; 4. The patient is not suitable or willing to undergo re-operation or other local treatment; 5. No extrahepatic bone metastasis or brain metastasis; 6. Child-Pugh liver function rating: A or better B (=12 weeks; 9. The main organs function normally, without serious underlying diseases; 10. women who are not breastfeeding or pregnant; 11. The subject voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known hepatobiliary cell carcinoma and mixed cell carcinoma and fibrolamellar cell carcinoma; previous (within 5 years) or concurrent other uncured malignancies; 2. Patients who are ready for liver transplantation (except those who have had a previous liver transplant); 3. Uncontrollable ascites, hepatic encephalopathy or esophageal variceal bleeding; 4. Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia 5. History of gastrointestinal bleeding or definite gastrointestinal bleeding tendency within the past 6 months, such as esophageal varices with bleeding risk, locally active ulcer focus, stool occult blood >= (++) cannot be enrolled; 6. Patients with extrahepatic bone metastasis or brain metastasis; 7. Pregnant or lactating women; those who are unable or unwilling to use effective contraception if they are fertile; 8. co-infected with HIV; 9. Other circumstances judged by the investigator that may affect the conduct of the clinical study and the judgment of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| PD-1 ;CTAL-4;overall survival;Objective response rate ,ORR;Disease Control Rate ,DCR; | — |
Countries
China
Contacts
Public ContactZheng Lu
The Second Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed