Malignant Tumor of Biliary System
Conditions
Interventions
Case series:No
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 80 years, male or female; 2. Patients with untreated primary advanced biliary malignancies (BTC) diagnosed by histopathology or cytology, including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), gallbladder cancer ( GBC); or untreated recurrent biliary tract tumors (surgery, adjuvant/neoadjuvant chemotherapy allowed in the past, recurrence >=3 months after the end of adjuvant chemotherapy, adjuvant/neoadjuvant chemotherapy regimen excluding PD-1/L1 monotherapy anti, gemcitabine, nab-paclitaxel, and cisplatin) 3. Physical condition ECOG PS score: 0-1 points; 4. Expected survival period >= 3 months; 5. According to RECIST 1.1 criteria, at least one measurable target lesion that can be examined by CT or MRI; 6. Laboratory inspection indicators meet the following requirements: (1) Bone marrow function: hemoglobin (Hb) >= 90g/L; white blood cell count (WBC) >= lower limit of normal; absolute neutrophil value (ANC) >= 1.5x10^9/L; platelet count >=100x10^9/L ; (2) Renal function: Cr=55 ml/min; (3) Liver function: total bilirubin38 degree; 12. Those who are expected to have good compliance can follow up the curative effect and adverse reactions according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors (except for carcinoma in situ, basal cell carcinoma, etc.) have been diagnosed within the past 5 years; 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. People who suffer from mental or nervous system disorders and cannot cooperate; 4. Patients who have previously received the medication regimen of this study (PD-1/L1 monoclonal antibody, albumin-bound paclitaxel, gemcitabine, cisplatin); 5. Patients who are planning to undergo or have previously received organ or bone marrow transplantation; 6. Suffer from any active autoimmune disease or autoimmune disease history; 7. Live vaccine has been vaccinated within 30 days before the first administration (injectable seasonal influenza vaccine is allowed because the vaccine is an inactivated vaccine); 8. Suffer from uncontrolled clinical symptoms or diseases of the heart; 9. Active infection or fever (except for clear tumor fever); 10. History or evidence of interstitial lung disease or active non-infectious pneumonia; 11. Those who suffer from other diseases are not suitable for entry, such as immunodeficiency, active tuberculosis, hepatitis B (hepatitis B virus titer HBV-DNA 10 mg/day of prednisone therapeutic effect within 14 days before enrollment; 14. Those who have received radiotherapy, chemotherapy, targeted therapy or immunotherapy within 4 weeks before enrollment; 15. Women during pregnancy or lactation; The researcher believes that it is not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactQuan Zhiwei
Xinhua Hospital affiliated to Shanghai JiaoTong University
Outcome results
None listed