Hepatocellular Carcinoma
Conditions
Interventions
Treatment group:HAIC plus Tislelizumab
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.; 3. Histological examination or clinical diagnosis of hepatocellular carcinoma; 4. BCLC stage C (CNLC IIIa), potentially resectable (R0 resectable, FLR adequate, Child-Pugh class A); 5. Radiologically confirmed PVTT; 6. At least one measurable lesion (according to RECIST1.1 criteria); 7. No previous treatment for HCC; 8. Child-Pugh Class A; 9. Routine blood tests and biochemical examinations: (1) Hb>= 90 g/L, ANC>= 1.5*10^9/L, PLT>= 50*10^9/L; (2) ALT and AST = 30g/L; (3) Cr< 1.5*ULN; (4) INR <= 2 or PT<= 6 seconds; 11. Appropriate to participate in this trial; 12. Male and female subjects of childbearing potential must agree to use an effective method of contraception throughout the study; 13. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Be hyperergic for PD-1; 2. Active malignancy at the same time. Cured tumors, including cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, prostate cancer, cervical cancer and breast cancer; 3. Gravidas or lactating women; 4. Presence of pericardial effusion, uncontrolled pleural effusion, or clinically significant ascites; 5. History of interstitial lung disease, pneumonitis, or uncontrolled systemic disease, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc.; 6. Patients with severe cardiovascular diseases within 12 months before enrollment, such as symptomatic coronary heart disease, >=II grade congestive heart failure, uncontrolled arrhythmia, myocardial infarction, etc.; 7. Presence of any active immunodeficiency or autoimmune disease and/or history of any immunodeficiency or autoimmune disease that may recur; 8. History of allogeneic organ transplantation; 9. Use of steroids or other systemic immunosuppressive therapy within 14 days prior to enrollment; 10. Patients with previously untreated other malignancies; 11. Immunocompromised patients, such as HIV positive; 12. With uncontrolled psychosis; 13. Other factors make the investigators think it is inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological response rate;Resection Rate;Recurrence-free survival;Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactHaibin Zhang
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed