cholangiocarcinoma
Conditions
Interventions
sigle group:Infusion of the new generation of domestic drug PD-L1 antagonist Adebelizumab injection: the dosage is 20mg/kg, once every 3 weeks, diluted with 250ml of 0.9% sodium chloride injection, th
12 mg/day orally for patients weighing more than 60 kg.
Sponsors
the Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Be 18-70 years of age (both 18 and 70 years); (2) Meet the diagnostic criteria for ICC and have lost the opportunity for surgical resection and have at least one measurable lesion; (3) Failed first-line chemotherapy (gemcitabine + cisplatin, etc.) or chemotherapy intolerance, and not using PD1/PDL1 monoclonal antibody or other drugs; (4) Genetic sequencing does not recommend a specific target drug. (5) Expected survival is more than 3 months (6) Physical condition with ECOG score 0-1; (7) Liver function: child-pugh score = B7, total bilirubin level 10g/dL; platelet count > 60,000/mm3 (the normal value in the research center is 85,000/mm3); (8) Normal cardiac function with cardiac ejection fraction > 50% and normal cardiac enzymes; (9) Women of childbearing age (15-49 years old) must have had a negative pregnancy test within 7 days prior to the start of treatment and must use contraception during the clinical trial and for at least 6 months after discontinuation of treatment; (10) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Pregnant and lactating women; 2) patients with organ insufficiency: e.g. cardiac insufficiency, renal insufficiency, pulmonary impairment; 3) Patients with a history of organ transplantation; (4) The presence of infectious or other serious diseases, including but not limited to infections (e.g., HIV-positive), congestive heart failure, unstable angina, cardiac arrhythmia, mental illness, or restriction of a compliant social environment, or those that, in the opinion of the attending physician, pose an unpredictable risk; (5) Patients with systemic autoimmune diseases or immunodeficiency diseases; (6) Patients with allergies; (7) Chronic diseases requiring immunologic or hormonal therapy; (8) Any other immunotherapy treatment in the previous period; (9) Participation in any other clinical trial within the previous 30 days; 10) have a history of hepatic encephalopathy, hepatorenal syndrome; (11) Pleural fluid, ascites, pericardial effusion with clinical symptoms requiring drainage; 12) Gene sequencing with a clear target drug recommendation; 13) Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;Time to Progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Objective Response Rate;Disease Control Rate;Duration of Response;Time To Response;progressive disease;partial response;complete response;stable disease;Adverse Events;quality of life assessment;TTD; | — |
Countries
China
Contacts
Public ContactZhen Zeng
the Fifth Medical Center of Chinese PLA General Hospital
Outcome results
None listed