Liver cancer
Conditions
Interventions
Experimental group:TACE+apatinib+camrelizumab
Sponsors
Department of Hepatobiliary Surgery, the Second Affiliated Hospital of PLA Army Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.HCC confirmed by imaging or histopathology; 2.BCLC stage B-C; 3.Recurrence within 2 years after operation; 4.It can not be resected again or can not tolerate surgery, and has not received TACE, ablation and other local treatment or systemic anti-tumor therapy for HCC; 5.ECOG score was 0-1; 6.The expected survival time is more than or equal to 3 months; 7.Child Pugh score <= 7; 8.Aged 18 to 65 years; 9.The subjects voluntarily joined the study and signed informed consent, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1.Uncontrollable ascites, hepatic encephalopathy or esophageal variceal bleeding; 2.Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 3.Suffering from myocardial ischemia or myocardial infarction above grade II and arrhythmia with poor control; 4.There are many factors influencing oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the medication and absorption); 5.Patients with history of gastrointestinal bleeding or definite tendency of gastrointestinal bleeding in the past 6 months, such as esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood >= (++), can not be included in the group; 6.With bleeding tendency or receiving thrombolytic or anticoagulant therapy; 7.Patients with central nervous system metastasis or known brain metastasis; 8.Urine routine showed that urine protein was >= + + or 24-hour urine protein was more than 1.0 g; 9.Pregnant or lactating women; Patients with fertility are unwilling or unable to take effective contraceptive measures; 10.The patient has any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism and hypothyroidism); Patients with vitiligo or asthma in childhood had complete remission, adult without any intervention can be included; Asthma patients who need bronchodilator for medical intervention can not be included; And so on); 11.The patient is using immunosuppressant or systemic or absorbable local hormone therapy to achieve the purpose of immunosuppression (dose > 10mg / day, prednisone or other therapeutic hormones), and continues to use it within 2 weeks before enrollment; The patient had received anti-PD-1 or PD-L 1 or CTLA-4 or CAR-T immunotherapy; 12.Severe allergic reaction to other monoclonal antibodies; 13.Patients preparing for liver transplantation (except those who have received liver transplantation in the past); Patients with extrahepatic metastases; 14.Joint HIV infection; 15.The researcher judges other situations that may affect the clinical research and the judgment of research results; 16.Patients with symptomatic BMS or controlled lesions after RADIOTHERAPY for BMS; 17.Laboratory routine examination (blood routine, liver and kidney function, coagulation function, etc.) showed significant abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;disease control rate;objective remission rate;life quality score; | — |
Countries
China
Contacts
Public ContactZheng Lu
Department of Hepatobiliary Surgery, the Second Affiliated Hospital of PLA Army Military Medical University
Outcome results
None listed