Advanced hepatocellular carcinoma with adverse reactions to routine administration
Conditions
Interventions
Experimental group:Patients receive oral lenvatinib once daily, administered via a "weekend-off" dosing schedule: Patients weighing >=60 kg receive 12 mg/day, while those weighing =60 kg receive 8 mg/
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. HCC is confirmed by histopathology or cytology and is inoperable; 2. Barcelona Clinic Liver Cancer (BCLC) is stage C; 3. Adverse reactions occurred during routine administration of lenvatinib (12mg/ day for patients with body weight >=60kg, 8mg/ day for patients with body weight =18 years old; 6. The physical status score of the Eastern Cooperative Oncology Group (ECOG) was 0 to 1; 7. The patient's organ system is functioning well, defined as follows: (1) Blood pressure =8.5g/dL; (4) Platelet (PLT)>=100×10^9/L; (5) Absolute neutrophil count (ANC) >=1.5×10^9/L; (6) Creatinine 1.5× upper limit of normal, creatinine clearance >=50mL/min calculated by Cockcroft-Gault formula, or urinary creatinine clearance >=50mL/min measured at 24 hours, the patients were still enrolled. 8. Willing and able to follow the test and follow-up procedures; 9. Be able to understand the nature of the test and voluntarily sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. The pathological results suggested mixed tumor; 2. Liver occupying>=50%, with obvious bile duct or portal vein invasion; 3. Women of childbearing age, pregnant or lactating women with positive serum pregnancy test 7 days before enrollment, or male and female subjects who did not take effective contraception or planned to give birth during the entire treatment period and 3 months after the end of treatment; 4. Previously received systemic drug therapy for liver cancer; 5. have multiple factors that affect oral drugs, such as swallowing dysfunction, active gastrointestinal disorders, or other diseases that significantly affect the absorption, distribution, metabolism, and excretion of lenvastinib; 6. Known allergic reactions to lenvatinib or any of its excipients; 7. other severe, acute, or chronic medical conditions that, in the investigator's opinion, may increase the risks associated with study participation or may interfere with the interpretation of study results, including uncontrolled diabetes or medical conditions or psychiatric disorders or laboratory abnormalities; 8. Other conditions deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event;Medication compliance;Response Rate, ORR;Disease control rate,DCR;Medication compliance;Medication compliance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Progression-Free Survival, PFS;Quality of life;Liver cancer quality of life; | — |
Countries
China
Contacts
Public ContactJiang Qian
Sichuan Cancer Hospital
Outcome results
None listed