Primary liver cancer
Conditions
Interventions
Experimental group:TACE in combination with camrelizumab and targeted therapy
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Patients with primary hepatocellular carcinoma who are strictly in line with the clinical diagnostic criteria of the (2019 edition) or diagnosed by histopathology or cytology, and have at least one measurable disease (According to the RECIST1.1 standard, the long diameter of the measurable lesion on spiral CT scan is >=10mm or the short diameter of the malignant lymph node is >=15mm); 3. Patients with unresectable intermediate and advanced primary hepatocellular carcinoma who have not received systemic therapy before; 4. CNLC stage is IIa-IIIb; 5. Child-Pugh grading of liver function is grade A (5-6 points); 6. ECOG PS score 0-1 points; 7. Expected survival period >= 12 weeks; 8. If the patient has active hepatitis B virus (HBV) infection: HBV-deoxyribonucleic acid (DNA) must be less than 2000 IU/mL (if the research center only has a copy/mL testing unit, it must be less than 12500 copy/mL), and received anti-HBV treatment (Treat according to local standard of care, eg entecavir) for at least 14 days before the start of study treatment and are willing to accept antiviral treatment throughout the study period; hepatitis C virus (HCV) ribonucleic acid (RNA) positive patients must receive antiviral therapy according to local standard treatment guidelines and have liver function within CTCAE grade 1 elevation; 9. The main organs function normally and meet the following criteria: (1) The blood routine examination standards must meet: (without blood transfusion within 14 days) hemoglobin (HB) >= 100g/L, white blood cell count (WBC) >= 3 x 10^9/L, absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet (PLT) >= 80 x 10^9/L; (2) Biochemical tests should meet the following criteria: bilirubin (BIL) <1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST <5ULN; serum creatinine (Cr) <=1.5ULN; 10. Female patients of childbearing age must have a negative pregnancy test (serum) or urine HCG test within 7 days before enrollment, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the trial drug; for males, surgical sterilization, or consent to use an appropriate method of contraception during the trial and 8 weeks after the last dose of the trial drug; 11. The patients voluntarily joined the study, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Lactating patients; 2. Patients with autoimmune diseases, organ/hematopoietic stem cell transplantation or other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 3. Patients with disturbance of consciousness or unable to cooperate with treatment, and patients with mental illness; 4. Patients who have participated in other clinical trials in the past three months; 5. Previously received targeted therapy, camrelizumab or other PD-1/PD-L1 inhibitor therapy; 6. Received major surgery or received chemotherapy, radiation therapy or other systemic therapy for the lesions within 1 month before enrollment; 7. Use immunosuppressive or systemic hormone therapy within 14 days before enrollment to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other equivalent hormones); 8. Liver function classification is Child-Pugh C, which cannot be improved by liver protection treatment; 9. Bleeding from esophageal (stomach fundus) varices within 1 month before treatment; 10. Uncorrectable coagulation dysfunction and severe blood abnormalities, with severe bleeding tendency. Platelet count 140 mmHg, diastolic blood pressure>90 mmHg); 16. Previous severe cardiovascular disease, including but not limited to the following diseases: myocardial ischemia or myocardial infarction above grade II, and poorly controlled arrhythmias (including QTc interval >=450 ms for men and >=470 ms for women); according to the NYHA standard, the patients with grade III-IV cardiac insufficiency, or the left ventricular ejection fraction (LVEF) 1.0g); 18. Inability to swallow tablets, malabsorption syndrome or any condition that affects gastrointestinal absorption; 19. According to the judgment of the investigator, patients with other concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 20. Patients with radiotherapy, targeted therapy and other contraindications to immunotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radical (R0) resection rate after conversion therapy;Conversion rates;Pathological complete response rate (pCR);Major pathological response rate (MPR);Progression-free survival (PFS);Disease control rate (DCR);Relapse-free survival time (RFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactZhang Zhibo
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed