154 Anshan Road, Tianjin, China
Conditions
Interventions
Case series:None
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years, gender is not limited; 2. Patients with unresectable or recurrent advanced intrahepatic cholangiocarcinoma (confirmed by pathology); 3. ECOG score is 0-1; 4. The expected survival period is more than 3 months; 5. There is at least one measurable lesion according to RECIST 1.1, and the lesion has not been irradiated; 6. The organ function level must meet the following requirements (7 days before the first administration of the study drug): (1) Blood routine: absolute neutrophil count (ANC) >= 1.5x10^9/L; platelet (PLT) >= 100x10^9/L; hemoglobin (HB) >= 9g/dL; (2) Liver function: total bilirubin concentration (TBIL) = 28 g/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50 mL/min; (4) International normalized ratio (INR) and activated partial thromboplastin time (APTT) <= 1.5 times ULN (5) Normal cardiac function (normal electrocardiogram, echocardiography showing left ventricular ejection fraction (LVEF) greater than 50%). 7. Women of childbearing age must have a negative serum pregnancy test result within 7 days before the first administration of the test drug; men with reproductive potential or women with the possibility of pregnancy should strictly take contraceptive measures from the date of signing the informed consent and end of treatment Continue contraception for 12 months. 8. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Mixed hepatocellular cholangiocarcinoma; 2. Previous anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA4 antibody, or other immunotherapy. Previously received targeted therapy against VEGF and/or VEGFR, RAF, MEK, PDGFR, FGFR and other signaling pathways; 3. Cancer embolus of main portal vein or inferior vena cava; 4. The patient has any active autoimmune disease or a history of autoimmune disease; 4. Patients with uncontrolled ascites or ascites that are difficult to control with diuretics and abdominocentesis; 5. Have any clinical problems beyond control, including but not limited to: persistent or active (severe) infection; Medically poorly controlled hypertension (blood pressure consistently greater than 150/90 mmHg); Poorly controlled diabetes; Severe heart failure, third degree atrioventricular block; 6. Active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis; 7. History of other tumors other than prior or concurrent ICC; 8. Any condition of the patient that affects the subject's ingestion of the drug and any condition that affects the absorption, distribution, metabolism, or excretion of the test drug in the body (e.g., history of gastrointestinal surgery, dysphagia, etc.); 9. A known history of allergic reactions to therapeutic drugs; 10. HIV infection; 11. Pregnant or nursing female patients; 12. Within the first 30 days, severe clinical bleeding symptoms or a clear tendency to gastrointestinal bleeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progress free survival;overall survival;disease control rate;duration of response; | — |
Countries
China
Contacts
Public ContactLiu Quanyan
Tianjin Medical University General Hospital
Outcome results
None listed