hepatocellular carcinoma
Conditions
Interventions
Treatment group:lenvatinib
Control group?:Sorafenib
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Patients with unresectable HCC confirmed as TACE failure; 2) Aged 18-70 years; 3) Patients with pathologically or cytologically confirmed hepatocellular carcinoma, or primary HCC according to the 2019 version of the Clinical Diagnostic Criteria for Primary HCC; 4) Patients with intermediate stage of primary HCC (BCLC stage B, CNLC stage IIa, IIb); 5) Patients with Child-pugh A or B liver function (= 7 points); 6) Patients with basically normal organ function: WBC = 3.0 * 109/L, PLT = 70 * 109/L, Hgb = 80 g/L; ALT = 5ULN, AST = 5ULN, TBIL = 3ULN, ALB = 28 g/L; CCr = 80ml/min; 7) Patients with non-radical surgery or liver transplantation indications; 8) Patients who voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Child-pugh class C or B = 8; 2) Previous use of other molecular targeted drugs, systemic chemotherapy or immunotherapy including but not limited to the following drugs: sorafenib, apatinib, regorafenib, PD-1 inhibitors or platinum-based or fluorouracil systemic chemotherapy; 3) Previous local treatment such as local radiation therapy or radiofrequency ablation within 1 month; 4) Active bleeding tendency; 5) Uncontrollable hypertension; 6) Combined with other incurable malignancies, except carcinoma in situ at other sites; 7) Active infection; 8) Cardiac insufficiency (NYHA = 2) or unstable angina pectoris, myocardial infarction within 1 year; 9) Chronic obstructive pulmonary disease resulting in SaO2 = 90% or dyspnea after activity; 10) Combined with active autoimmune diseases such as Sjogren 's syndrome, lupus erythematosus, etc.; 11) Patients with severe mental disorders who cannot give informed consent or cooperate with this protocol; 12) Patients who use warfarin anticoagulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Safety; | — |
Countries
China
Contacts
Public ContactWei Sun
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed