biliary tract cancer
Conditions
Interventions
Experimental group:Camrelizumab,200 mg,IV,Q3W
irinotecan liposome(II)IV, Q3W
Surufatinib :200mg,PO,QD
Sponsors
Peking University International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. signed written informed consent before enrollment; 2. age > 18 years, both sexes; 3. patients with histologically or pathologically confirmed advanced biliary systemic malignancies; 4. progression/intolerance after prior systemic therapy; 5. having a measurable lesion (>=10 mm long diameter on CT scan for non-lymph node lesions and >=15 mm short diameter on CT scan for lymph node lesions according to RECIST 1.1 criteria); 6. ECOG PS score: 0-2; 7. expected survival > 12 weeks; 8. The function of vital organs meets the following requirements (excluding the use of any blood components and cell growth factors within 14 days): 1) Blood count: Neutrophils >= 1.5 x 109/L; Platelet count >= 75 × 109/L; Hemoglobin >= 80g/L; 2)Liver and kidney function: Serum creatinine (SCr) =50 ml/min (Cockcroft-Glasswell). (Cockcroft-Gault formula); Total bilirubin (TBIL) =2+, 24-hour urine protein quantification must show <=1 g of protein; 9. normal coagulation function without active bleeding and thrombotic disorders: 1) International Normalized Ratio INR <= 1.5 x ULN; 2) partial thromboplastin time APTT <=1.5 x ULN; 3) Prothrombin time PT <= 1.5 x ULN; 10. non-surgically sterilized or female patients of childbearing age, who are required to use a medically approved contraceptive method (e.g., intrauterine device, birth control pills, or condoms) during the study treatment period and for a period of 3 months after the end of the study treatment period; non-surgically sterilized female patients of childbearing age, who must have had a negative serum or urinary HCG test for a period of 7 days prior to study enrollment; and who must not be breastfeeding; non-surgically sterilized or male patients of childbearing age, who need to consent to their spouse's participation in the study. patients, will need to agree to use a medically approved form of contraception with their spouse for the duration of study treatment and for 3 months after the end of the study treatment period; 11. Subjects voluntarily enroll in the study, are compliant, and cooperate with safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. the subject has a prior or concurrent history of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 2. the subject has a known prior allergy to large protein preparations, or a known allergy to the components of the applied drug; 3. the subject has any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, and those who have had previous thyroid surgery cannot be included; subjects with vitiligo or asthma that has been in complete remission in childhood and in adulthood (those who do not require any intervention can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included); 4. subjects who are on immunosuppressive, or systemic, or absorbable topical hormone therapy for immunosuppression (doses >10mg/day prednisone or other equipotent hormone) and who continue to use it within 4 weeks prior to enrollment; 5. patients with uncontrolled cardiac clinical conditions or disease such as (1) NYHA class 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 6. subjects with active infections or unexplained fever >38.5 degrees occurring during the screening period, prior to the first dose (at the investigator's discretion, subjects may be enrolled with fever arising from a tumor); 7. patients with previous and current objective evidence of a history of pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonitis, or severely impaired lung function; 8. subjects with congenital or acquired immune function defects such as HIV infection; 9. vaccination with live vaccines less than 4 weeks prior to study drug administration or possibly during the study; 10. subjects with a known history of psychotropic substance abuse, alcoholism, or drug addiction; 11. patients who are unable to administer the drug orally; 12. having received herbal or proprietary Chinese medicines with antitumor indications within 2 weeks prior to the first dose; 13. in the opinion of the investigator, should be excluded from the study, for example, in the judgment of the investigator, the subject has other factors that may cause the study to be forced to terminate in the middle of the study, such as, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, severe fundal esophageal varices, severe laboratory test abnormalities, accompanied by family or social factors, which would affect the safety of the subject, or the collection of data and samples. 14. the subject has been treated with a liposome analog of sofentinib or irinotecan for frontline therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall Survival;Disease Control Rate;Adverse Events; | — |
Countries
China
Contacts
Public ContactLi Li
Peking University International Hospital
Outcome results
None listed