Cholangiocarcinoma
Conditions
Interventions
Treatment group:HAIC+camrelizumab plus apatinib
Control group:HAIC
Sponsors
Shandong Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Patients were confirmed for primary cholangiocarcinoma by histopathology or cytology with the diagnostic and therapeutic criteria for primary liver cancer" (2019 Edition); 3. Child Pugh liver function: Grade A or better grade B (= 90 g/L ANC >= 1.5 x 10^9/L PLT >= 60 x 10^9/L (2) Biochemical examination: ALB >= 29 g/L ALT and AST were < 2.5 ULN; TBIL <= 2 ULN Creatinine <= 1.5 ULN; (only one of albumin and bilirubin in child Pugh rating is 2 points). 9. Women of childbearing age should exclude the possibility of pregnancy before entering the group; 10. The subjects joined voluntarily the study, without mental illness or other mental symptoms, with full civil capacity. The subjects need signed informed consent, have good compliance, and can cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients had used targeted drugs who was hepatocellular carcinoma with vascular invasion or extrahepatic metastasis; 2. The main portal vein was embolized by tumor thrombus; 3. Patients were treated by any local treatment (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation or percutaneous ethanol injection) other than HAIC within 4 weeks before participating in the study; 4. The subjects had any active autoimmune diseases or history of autoimmune diseases (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood had been completely relieved, and no need for any after adulthood Intervention can be included; asthma patients who need bronchodilator for medical intervention cannot be included; 5. To achieve the purpose of immunosuppression,the subjects were using immunosuppressive agents, and systemic or absorbable local hormone therapy (dosage > 10mg / Day, prednisone or other effective hormones), and continued to use them within 2 weeks before enrollment; 6. The subjects had severe allergic reaction to the test drug; 7. There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above; (2) unstable angina pectoris; (3) myocardial infarction occurred within 1 year; (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention; (5) QTc > 450ms (male); QTc > 470ms (female) 8. Abnormal coagulation function (INR > 1.5 or PT > 16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy; 9. Subjects who had previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy and were less than 4 weeks away from the last medication or treatment (or 5 drug half-life, the longer one should be selected); patients whose adverse events (except hair loss) caused by previous treatment did not recover to = CTCAE 1 degree; 10. Patients with ascites, pleural effusion and pericardial effusion with clinical symptoms that need therapeutic puncture or drainage, such as those with stable pleural effusion and pericardial effusion after drainage and observed for at least 2 weeks before the first drug use in the study can be included in the study; 11. Patients with severe abnormal liver function and coagulation function within 2 months before randomization; 12. Known hereditary or acquired bleeding and thrombotic tendency (such as hemophilia patients, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or the occurrence of arteriovenous thrombosis events in the past 6 months (up to the enrollment); 13. Active infection or unexplained fever > 38.5 degree occurred during screening and before the first administration; 14. Patients with a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe impairment of lung function; 15. Subjects with congenital or acquired immune deficiency (e.g. HIV infected person), or active hepatitis (reference for hepatitis B: HBV DNA test value exceeding the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA detection value exceeding the upper limit of normal value); 16. Those who have used other drug clinical trial research drugs or similar treatment drugs wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactJianjun Han
Shandong Cancer Hospital
Outcome results
None listed