Biliary Tract Tumors
Conditions
Interventions
Treatment:Envolizumab+chemotherapy
Sponsors
QingDao Central Medical Group
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent form before joining the group; 2. Advanced biliary system tumors without systemic treatment or biliary system tumors that recur after 6 months of postoperative adjuvant treatment; 3. Age range from 18 to 75 years old, both male and female; 4. ECOG PS=0-1; 5. Expected survival time = 3 months; 6. The functions of important organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days): 1) Blood routine: 2) Neutrophils = 1.5 × 109/L 3) Platelet count = 100 × 109/L 4) Hemoglobin = 90g/L; 7. Liver and kidney function: 1) Serum creatinine (SCr) = 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate = 50 ml/min (Cockcroft Fault formula); 2) Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); 3) The level of Aspartate transaminase (AST) or Alanine transaminase (ALT) = 2.5 times the upper limit of normal value (ULN) (= 5ULN if abnormal liver function is caused by liver metastasis); Urinary protein<2+; If the urine protein is = 2+, the 24-hour urine protein quantitative display must be = 1g; 8. Normal coagulation function, no active bleeding or thrombosis disease 1) International standardized ratio INR = 1.5 × ULN; 2) Partial thromboplastin time APTT = 1.5 × ULN; 3) Prothrombin time PT = 1.5 × ULN; 9. Non operative sterilization or female patients of childbearing age need to use a medically approved contraceptive measure (such as Intrauterine device, pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; Non surgically sterilized female patients of childbearing age must have a negative serum or urine HCG test within 7 days before enrollment in the study; And it must be non lactating; Non surgical sterilization or male patients of childbearing age are required to agree to use a medically approved contraceptive method with their spouse during the study treatment period and within 3 months after the end of the study treatment period. 10. The subjects voluntarily joined this study with good compliance, safety, and survival follow-up.
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions cannot be included in this study: 1. Subjects have suffered from other malignant tumors in the past or at the same time (except cured skin Basal-cell carcinoma and cervical Carcinoma in situ); 2. The subject is known to have previous allergies to macromolecular protein formulations, or to any components or excipients of the drug used; 3. Subjects with any active autoimmune disease or history of autoimmune disease (such as, but not limited to: Autoimmune hepatitis, interstitial pneumonia, Uveitis, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism, those who have had thyroid surgery in the past cannot be included); 4. The subject is using Immunosuppressive drug, or systemic or absorbable local hormone treatment to achieve the purpose of immunosuppression (dose>10mg/day prednisone or other therapeutic hormones), and continues to use it within 2 weeks before enrollment; 5. Therapeutic puncture or drainage is required for ascites or Pleural effusion with clinical symptoms; 6. Patients with clinically uncontrollable cardiac symptoms or diseases, such as: (1) NYHA grade 2 or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention; 7. The subjects were still using traditional Chinese medicine immunomodulators within 2 weeks before enrollment; 8. The subject has an active infection or an unexplained fever>38.5 ? during the screening period or before the first administration (according to the researcher's judgment, the subject's fever caused by the tumor can be included in the group); 9. Subjects have congenital or acquired immune deficiency, such as HIV infected persons or active hepatitis (Transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA = 1000 IU/ml; hepatitis C reference: HCV RNA = 1000 IU/ml); Chronic hepatitis B virus carriers with HBV DNA<2000 IU/ml must receive antiviral treatment simultaneously during the trial period before they can be enrolled; 10. Live vaccines may be administered less than 4 weeks before the study medication or during the study period; 11. The subject is known to have a history of psychotropic substance abuse, alcoholism, or drug abuse; 12. The researcher believes that it should be excluded from this study. For example, based on the researcher's judgment, the subject may have other factors that may cause the study to be terminated midway, such as other serious diseases (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which may affect the safety of the subject, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactLiangHua
QingDao Central Medical Group
Outcome results
None listed