HCC
Conditions
Interventions
Experimental Group:Transcatheter arterial chemoembolization + Apatinib + Camrelizumab
Control Group:Transcatheter arterial chemoembolization
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70, any gender. 2. HCC patients diagnosed per the 2019 Clinical Diagnosis Criteria or confirmed by pathology or cytology. 3. No prior local or systemic HCC treatment in the last 4 weeks, open to postoperative preventive TACE. 4. ECOG PS score 0-1. 5. Child-Pugh liver function class A. 6. Initial liver resection as R0, no Vp3/Vp4 vessel invasion, no vascular invasion of hepatic vein or inferior vena cava; postoperative confirmation of no residual lesions. 7. Postoperative recurrence and unresectable: a. Recurrence after liver resection. b. BCLC B-stage HCC with multiple lesions (>3 or =4 tumors confined to the liver). c. Single lesion >5cm with inadequate residual liver volume for curative treatment. 8. Measurable lesion per mRECIST criteria. 9. HBsAg positive with HBV-DNA 40 mL/min). e. Adequate pancreatic function. f. Normal thyroid function or controlled thyroid dysfunction. 11. Controlled blood pressure (BP <= 150/90mmHg) with up to 3 antihypertensive drugs. 12. Expected survival over 3 months. 13. Not pregnant or planning pregnancy. 14. Voluntary participation, signed informed consent, good compliance, and cooperation with follow-ups.
Exclusion criteria
Exclusion criteria: (1) Extrahepatic metastasis of primary liver cancer; (2) Tumor lesions =10 cm and >10 lesions, or intrahepatic tumor burden =50% of liver volume, or/and portal vein tumor thrombus, or/and hepatic vein tumor thrombus, or/and inferior vena cava tumor thrombus, as confirmed by BICR; (3) Contraindications to TACE and epirubicin; (4) Participation in other clinical trial drugs within 4 weeks; (5) Known hypersensitivity to the active ingredients and excipients contained in the study drugs (carrelizumab, apatinib) of this study, or a history of severe allergy to any other monoclonal antibodies or anti-angiogenic targeted drugs; (6) History of liver transplantation, radiofrequency/microwave ablation treatment; (7) Pregnant or lactating women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; (8) Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval = 470ms); grade III to IV heart failure according to NYHA standards, or left ventricular ejection fraction (LVEF 1.5 or prothrombin time (PT) > ULN + 4 seconds or APTT > 1.5 ULN), bleeding tendency or receiving (10) Patients with mental illness or history of abuse of psychotropic drugs; (11) Patients with congenital or acquired immune deficiency (such as HIV infection); (12) Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; (13) Severe infection within 4 weeks before the start of study treatment, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia; Oral or intravenous therapeutic antibiotics within 2 weeks before the start of study treatment (receiving prophylactic antibiotics, such as to prevent urinary tract infection or chronic Patients with exacerbation of obstructive pulmonary disease are eligible to participate in the study); (14) Patients with poor compliance, such as migrant population; (15) Patients who have previously received the following therapies: anti-VEGF2, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that target another stimulatory or synergistic inhibitory T cell receptor (e.g., CTLA-4, OX-40, CD137); (16) Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids or immunosuppressants) within 2 years before the first dose. Replacement therapy (such as thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic treatment; (17) Patients who are receiving systemic glucocorticoid therapy (excluding local glucocorticoids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days before the first dose of the study; Note: Physiological doses of glucocorticoids (=10 mg/day of prednisone or equivalent drugs) are allowed; (18) Patients with clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need to drain the effusion or who have no significant increase in the effusion after cessation of drainage for 3 days can be included in the group); (19) Patients with acute or chronic active hepatitis B or hepatitis C infection, hepatitis B virus HBVDNA = 200,000 IU/ml or 10^6 copies/ml; hepatitis C virus HCVRNA = 10^3 copies/ml; hepatitis B surface antig
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Safety and Tolerability;ORR;DCR;DOR;OS; | — |
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
china
Contacts
Public Contactwen tianfu
west china hospital, sichuan university
Outcome results
None listed