hepatocellular carcinoma
Conditions
Interventions
Case series:Nil
Sponsors
Zhongshan Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged >=18 years old; 2. Hepatocarcinoma cells that are clinically diagnosed or confirmed by histology or cytology in accordance with the "Standards for the Diagnosis and Treatment of Primary Liver Cancer" (Ministry of Health 2017 Edition); 3. Patients with unresectable or metastatic hepatocellular carcinoma; 4. There is at least one measurable lesion: (1) Definition of measurable lesion: non-lymphatic lesions with longest diameter >=10mm, or lymphoid lesions with short diameter >=15mm; (2) The lesions after previous intervention, radiotherapy or ablation treatment have clearly progressed according to the RECIST1.1 standard, and the longest diameter >=10mm, which can also be used as the target lesion; 5. The patient understands and is willing to sign the informed consent form; 6. The patient's Eastern Cooperative Oncology Group (ECOG) physical status score is 0 or 1; 7. The patient's bone marrow function, liver function and renal function requirements: absolute neutrophil count (ANC) >=1.5x10^9/L, platelet count >=75x10^9/L; serum creatinine 40mL /min; total bilirubin<=1.5 ULN, AST and ALT <=5 ULN; prothrombin time-international normalized ratio (PT-INR)<=2.3 ULN; 8. The patient received PD-1 monoclonal antibody combined with lenvatinib treatment.
Exclusion criteria
Exclusion criteria: 1. The patient is currently receiving or has received anti-cancer treatment in the past 2 weeks; 2. The patient is currently receiving or has received irradiation or local treatment for the target lesion within the past 2 weeks; 3. The patient had undergone major surgery within 14 days before entering the study (needle biopsy is not included); 4. The patient has metastatic brain lesions. Patients who are asymptomatic and well controlled for at least 4 weeks can be enrolled; 5. The patient has a history of any other malignant tumors, unless the remission period exceeds 1 year; skin cancer and cervical carcinoma in situ after radical treatment are not considered as exclusion criteria; 6. Female patients are pregnant or breastfeeding; 7. The patient has received any test drug within 14 days before receiving the first drug administration; 8. The HIV test result of the known patient is positive, active hepatitis C, or hepatitis B infection and the hepatitis B virus DNA exceeds 2000 IU/mL; 9. The patient has a known active or suspected autoimmune disease. Subjects who are in a stable state and do not need systemic immunosuppressive therapy are allowed to enter the group. Subjects who require corticosteroids (>10mg/day prednisone therapeutic dose) or other immunosuppressive agents for systemic treatment within 14 days before the administration of the study drug. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal hormone replacement with a dose of> 10 mg/day prednisone are allowed. The patients baseline corrected QT interval QTc>450ms, or the patient has the following conditions: known QT prolonged syndrome, torsade de pointes ventricular tachycardia, symptomatic ventricular tachycardia, 3 months before the screening visit Unstable heart syndrome, >Grade 2 New York Heart Association heart failure, >Grade 2 Canadian Cardiovascular Association angina, or receiving quinidine, procainamide, disopyramide, amiodarone, droneida Polyuron, arsenic, dofetilide or sotalol methadone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cfDNA-5hmC; | — |
Countries
China
Contacts
Public ContactCai Jiabin
Zhongshan Hospital of Fudan University
Outcome results
None listed