Biliary tract cancer
Conditions
Interventions
The experimental grou:gemcitabine
Sponsors
Jiangsu Provincial People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed biliary malignancies, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer, with immunohistochemical findings indicating positive PD-L1 (TPS >=1% or IPS >=1%); 2. Aged 18 to 75 years; 3. Expected survival >=3 months; 4. ECOG score 0-1; 5. At least 1 measurable lesion, according to RECIST 1.1; 6. No prior treatment with apatinib mesylate, gemcitabine and PD-1/PD-L1 monoab.Patients who had relapsed at least 6 months after the end of postoperative adjuvant chemotherapy with gemcitabine, or who had failed first-line treatment with platinum/tecio/capecitabine, etc., could be included. The number of previous advanced treatment lines was no more than 1 line; 7. The function of major organs is good, that is, the relevant examination indicators within 14 days before enrollment meet the following requirements: Hemoglobin >=90 g/L (no blood transfusion within 14 days); Neutrophil count & GT; 1.5x10^9/L; Platelet count >=100x10^9/L; Total bilirubin =60 ml/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=50%; 8. The informed consent was signed and the compliance was good. The family members agreed to cooperate with the survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Previous or concurrent malignancies, except basal cell carcinoma of the skin and carcinoma in situ of the cervix, which have been cured; The exceptions were microscopic gastric stromal tumors, other early tumors after radical treatment, and other tumors that the researchers determined did not affect the patient's life in the short term. 2. Participated in other drug clinical trials within 4 weeks; 3. Patients with known CNS metastasis or a history of CNS metastasis before screening. For patients clinically suspected of central nervous system metastasis, CT or MRI examination must be performed within 28 days before enrollment to exclude central nervous system metastasis; 4. A history of unstable angina pectoris; Screening for newly diagnosed angina within 3 months or myocardial infarction within 6 months prior to screening; Arrhythmias (including QTcF: >=450 ms for men and >=470 ms for women) require long-term use of anti-arrhythmias and New York Heart Association grade >=II cardiac dysfunction; 5. Urine routine indicated urinary protein >=++ and confirmed 24-hour urinary protein quantification>1.0 g; 6. For female subjects: for surgical sterilization, postmenopausal patients, or consent to use a medically approved contraceptive method during the study treatment period and for a period of 6 months after the end of the study treatment period; The serum or urine pregnancy test must be negative within 7 days prior to study inclusion and must be non-lactating. For male subjects: patients who should be surgically sterilized or who have agreed to use a medically approved contraceptive method during the study treatment period and for a period of 6 months after the end of the study treatment period; 7. Immunological and antiangiogenic drugs have been used; 8. A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other conditions requiring corticosteroid use; 10. History of chronic autoimmune diseases, such as systemic lupus erythematosus; History of inflammatory bowel diseases such as ulcerative enteritis and Crohn's disease, and History of chronic diarrheal diseases such as irritable bowel syndrome; History of sarcoidosis or tuberculosis; History of active hepatitis B and C and HIV infection; 11. Patients with high sensitivity to human or mouse monoclonal antibodies; 12. Has a history of substance abuse and is unable to quit or has a mental disorder; 13. Pleural effusion or peritoneal effusion with clinical symptoms requiring clinical intervention; 14. Concomitant disease that, in the investigator's judgment, would seriously endanger the patient's safety or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS; | — |
Contacts
Public ContactXiaofeng Chen
Jiangsu Provincial People's Hospital
Outcome results
None listed