biliary tract cancer
Conditions
Interventions
experimental group:albumin-bound paclitaxel combined with carrelizumab and apatinib
Sponsors
The First Affiliated Hospital Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years; 2. pathologically diagnosed as advanced biliary tract cancer; 3. Not suitable for surgery and local treatment; 4. ECOG PS 0 to 1; 5. had progressed on or were intolerant to previous systemic treatment; 6. According to the RECIST 1.1 , there is at least one measurable lesion; 7. A predicted life expectancy longer than 12 weeks; 8. Adequent organ function; 9. Women of childbearing age must take a pregnancy test (serum or urine) within 3 days before joining the group, and the result is negative, and are willing to take effective contraceptive measures during the entire study period 10. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Suffered from other uncured malignant tumors in the past (within 5 years) or at the same time, for the localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ And breast carcinoma in situ can be included in the group; 2. Those with known central nervous system metastasis (except those with stable disease control and asymptomatic 4 weeks after radiotherapy or surgery) or evidence of cancerous meningitis; 3. Patients who have previously received the medication regimen of this study (albumin-bound paclitaxel combined with carrelizumab and apatinib); 4. Patients who are going to undergo or have previously received organ or bone marrow transplantation; 5. Ascites with clinical symptoms, that requires therapeutic abdominal puncture or drainage, or ChildPugh score > 2; 6. Within 6 months before signing the informed consent, such as: esophageal varices with bleeding risk, local active ulcer lesions, persistent fecal occult blood positive can not be included in the group; 7. Suffering from hypertension, who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure> 140 mmHg, diastolic blood pressure > 90 mmHg); 8. Suffering from myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia or above myocardial ischemia or infarction, poorly controlled arrhythmia (QTc interval >=450 ms)(QTc interval is calculated by Fridericia formula); 9. Had an abdominal fistula, gastrointestinal perforation or abdominal abscess in the 28 days before participating in this study; 10. Past and current patients with objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severely impaired lung function, etc.; 11. Urine routine shows urine protein >= ++ or confirmed 24-hour urine protein quantitative > 1.0 g; 12. The subject has a known active or suspected autoimmune disease; 13. Subjects who require corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 14 days before the study drug is administered; Have used anti-tumor vaccine or other anti-tumor drugs with immunostimulating effect within 3 months; 15. Known to have a history of severe allergy to any monoclonal antibody; 16. Those who have been confirmed to be allergic to albumin-bound paclitaxel and/or its excipients; 17. Pregnant or breastfeeding women; fertility patients who are unwilling or unable to take effective contraceptive measures; 18. Untreated active hepatitis (hepatitis B: HBsAg positive and HBV-DNA>=2000 IU/mL; hepatitis C: HCV-RNA positive and liver function is obviously abnormal); combined hepatitis B and hepatitis C co-infection; 19. Suffer from congenital or acquired immune function defects (such as HIV infection); 20. Researchers judge other situations that are not suitable for research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Countries
China
Contacts
Public ContactHaiping Jiang
The First Affiliated Hospital Zhejiang University
Outcome results
None listed