Hepatocellular carcinoma
Conditions
Interventions
Lenvatinib: oral, once a day, based on patients weight (60 kg: 12 mg).
Sponsors
The First Affiliated Hospital of Anhui University of Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form; 2. Age>=18 years old, male or female; 3. Subjects with hepatocellular carcinoma confirmed by pathological histology, cytology or imaging; 4. Not suitable for radical treatment, such as surgical resection, ablation, and liver transplantation; 5. Subjects with CNLC stage IIb/IIIa/IIIb or BCLC stage B/C hepatocellular carcinoma; 6. Child-Pugh liver function rating: A~B (=6 months; or subjects who have received curative therapy for localized HCC (such as surgical resection, radiofrequency ablation, liver transplantation, etc.), and the interval between the end of treatment and disease recurrence/progression is >=6 months; Subjects who have received local therapy (such as TACE, HAIC, etc.) but have not progressed are allowed to be enrolled in this study; 8. At least 1 measurable lesion (assessed based on RECIST v1.1); 9. ECOG physical performance status score (PS score) 0 or 1; 10. Estimated survival >=3 months; 11. The functional level of vital organs within 3 days prior to the first dose must meet the following requirements (supportive therapy, such as any blood components and cell growth factors, is not allowed within 14 days prior to the first dose): (1) Absolute neutrophil count>=1.5×10?/L; (2) Platelet >=90×10?/L; (3) Hemoglobin >=90 g/L; (4) Serum albumin>=30 g/L; (5) AST and ALT 1.5×ULN, the creatinine clearance rate (CLcr) calculated by the Cockcroft-Gault equation was >=50 mL/min; (8) Left ventricular ejection fraction (LVEF) >50%; (9) Proteinuria =2+, 24-hour urine protein should be quantified, and <=1 g can be selected); (10) International normalized ratio (INR) <=1.5, activated partial thromboplastin time (APTT) <=1.5×ULN; 12. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must < 500 IU/mL (if the research center only has a copy/mL testing unit, it is required.) <2500 copy/mL) and have received anti-HBV therapy (according to local standard therapy, e.g., entecavir) for at least 14 days prior to the start of study treatment and are willing to receive antiviral therapy throughout the study period; Hepatitis C virus (HCV) ribonucleic acid (RNA)-positive patients must be on antiviral therapy according to local standard treatment guidelines and have elevated liver function within CTCAE grade 1; 13. Women of childbearing age must test negative for pregnancy (ß-HCG) before starting treatment, and women of childbearing age and men (who have sex with women of childbearing age) must agree to contraception during treatment and within 6 months of the last treatment; 14. Patients who are considered by the investigator to be beneficial.
Exclusion criteria
Exclusion criteria: 1. Known hepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; Active malignancy other than HCC within 5 years or concurrently at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., can be enrolled; 2. Patients who are about to undergo or have previously received organ or allogeneic bone marrow transplantation; 3. Child-Pugh grade C of liver function; 4. Liver tumor burden exceeds 50% of the whole liver, or combined with inferior vena cava cancer thrombosis or superior mesenteric vein cancer thrombosis; 5. There are contraindications to the use of targeted drugs or immune checkpoint inhibitors; 6. Serious comorbidities, including severe heart, lung, kidney, coagulation dysfunction, important cardiovascular diseases (such as unstable arrhythmia, unstable angina pectoris and myocardial infarction, etc.); 7. Pregnant and lactating women; 8. Received chemotherapy and molecular targeted drugs for the treatment of advanced hepatocellular carcinoma; 9. Previous treatment with the following: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other immunotherapy (such as anti-CTLA-4, anti-CD137, etc.); 10. Systemic infection or other serious infection requiring intravenous antibiotics > 7 days for treatment within 2 weeks before the first dose, or unexplained fever > 38.5°C during the screening period and before enrollment (except for the fever caused by tumor in the judgment of the investigator); 11. Diagnosed with immunodeficiency or treated with systemic steroids or any other form of immunosuppressive therapy or immunomodulators within 7 days prior to the first dose of study drug; 12. Significant clinically significant bleeding symptoms or clear bleeding tendency within 6 months before enrollment, such as gastrointestinal bleeding, severe esophageal and gastric varices, hemorrhagic gastric ulcer or vasculitis, etc., if the fecal occult blood is positive in the baseline period, it can be retested, and if it is still positive after reexamination, gastroscopy is required; 13. Known hereditary or acquired bleeding (such as coagulation dysfunction) or thrombotic tendency, such as hemophilia patients, coagulation mechanism disorders, thrombocytopenia, etc.; Currently receiving full-dose oral or injectable anticoagulant drugs or thrombolytic drugs for therapeutic purposes (prophylactic use of low-dose aspirin is allowed, etc.); 14. Arterial thromboembolic events have occurred within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis above CTCAE level 3, pulmonary embolism, etc.; 15. Symptomatic central nervous system (CNS) metastases; 16. Have an active or potentially recurrent autoimmune disease; 17. Those who have interstitial lung disease, pneumoconiosis, and radiation pneumonitis in the past and/or at present, and those who have been assessed by the investigator to be clinically significant, as well as those with severe impairment of lung function that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity; 18. HIV-positive patients; Those who are known to have received anti-tuberculosis therapy within one year prior to the first dose of study treatment; Know
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;Time to Response;Overall Survival;Adverse Events; | — |
Countries
China
Contacts
Public ContactYong Wang
The First Affiliated Hospital of Anhui University of Technology
Outcome results
None listed