Biliary tract cancer
Conditions
Interventions
HIPEC combined with CRS and durvalumab treatment group:HIPEC combined with CRS and durvalumab
Sponsors
The Third Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with histologically confirmed unresectable advanced or metastatic biliary tract tumors with peritoneal metastasis (including cholangiocarcinoma and gallbladder cancer); 2. Patients with BTC who had unresectable or metastatic BTC at the time of initial diagnosis and had not received prior treatment. 3. Patients who have received prior curative therapy (surgery and chemotherapy and/or radiotherapy given in adjuvant therapy) with disease recurrence > 6 months. Patients with residual lesions after surgery who have received chemotherapy, chemoembolization or radiotherapy are included. 4. World Health Organization (WHO)/ECOG performance status score (PS) of 0 or 1 (preoperative Carinthian performance status score (KPS) score of 70 at the time of inclusion; 5. At least 1 lesion compliant with RECIST 1.1 target lesion (TL) at baseline. 6. Patients with HBV infection (characterized by HBsAg positive and/or anti-HBcAb positive according to local laboratory standards with detectable HBV DNA) must receive antiviral therapy as per institutional practice to ensure adequate viral suppression (according to local laboratory standards) prior to inclusion. Subjects need to continue receiving antiviral therapy during the study and 6 months after receiving the last dose of study intervention. Antiviral therapy prior to inclusion in the study is not required for patients with a positive anti-HBc test but no detectable HBV DNA (according to local laboratory standards). These subjects will be tested at each cycle to monitor HBV DNA levels and to start antiviral therapy (according to local laboratory standards) after HBV DNA is detected. Subjects with detectable HBV DNA must start and continue antiviral therapy during the study and 6 months after receiving the last dose of study intervention. 7. Good organ and bone marrow function: hemoglobin>= 9.0 g/dL. Absolute neutrophil count >= 1.5 × 10^9 /L. Platelet count >= 100 × 10^9/L. 8. Serum bilirubin 50 mL/min. For chemotherapy regimens containing cisplatin, oxaliplatin, or gemcitabine, the recommended threshold for creatinine clearance calculated by Cockcroft- Gault (based on actual body weight) or 24-hour urinary creatinine clearance assay should > 40 mL/min. 10. The expected lifespan is at least 12 weeks.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test result at baseline; 2. Diagnosed with central nervous system metastasis by CT/MR/PET-CT; 3. Previously received anti-tumor treatment such as live vaccination or radiotherapy; 4. Patients who have participated in or are participating in other drug or therapy clinical trials within 4 weeks before the first dose of study drug; 5. Patients who have undergone major surgical procedures within 4 weeks before the first dose of study drug or have not recovered from the side effects of this surgery, and have undergone radiotherapy within 2 weeks before the first dose of study drug; 6. Patients with any primary immunodeficiency disease, active autoimmune disease, or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo, and asthma, who have completely resolved asthma in childhood and do not need any intervention in adulthood. Asthma patients requiring bronchodilators for medical intervention cannot be included; 7. Patients with a known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, as well as those who are using hormone therapy such as immunosuppressants or steroids for immunosuppressive purposes (dose > 10mg/day prednisone or other equivalent efficacy hormones), and continue to use them within 2 weeks before enrollment; 8. Other malignancies other than biliary tract malignancies in the past 5 years, except for cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, early prostate cancer, cervical cancer in situ, or breast cancer; 9. Patients who have received hematopoietic stimulating factors, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin and other treatments within 1 week before the first dose of study drug; 10. Patients with positive test results for acquired immunodeficiency virus (HIV) antibody or Treponema pallidum antibody, and active viral hepatitis B or C; 11. Known allergy to recombinant humanized PD-L1 monoclonal antibody drugs and their components; 12. Severe cardiovascular disease within 12 months before enrollment, such as coronary heart disease with obvious clinical symptoms, congestive heart failure of NYHA= class II, uncontrolled arrhythmia, myocardial infarction; 13. The following conditions occurred within 6 months before the first dose: deep vein thrombosis or pulmonary embolism; ?myocardial infarction; ?Severe or unstable arrhythmia or angina; ?percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism. 14. Subjects who have undergone any kind of gastrointestinal surgery, or are complicated by upper gastrointestinal obstruction, bleeding, abnormal digestive function or malabsorption syndrome, which may affect the absorption of the study drug; 15. Concurrent serious uncontrolled concurrent infection or other serious uncontrolled concomitant disease, moderate or severe renal injury; 16. Active pulmonary disease, such as interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma, or a history of active tuberculosis. 17. Abnormal coagulation function (INR>2.0, PT>16s), with bleeding tendency or receiving thrombolytic or anticoagulant therapy, low-dose aspirin, low molec
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate of Ascites Lesions;Objective response rate,ORR;Progression free survival (PFS);Safety; | — |
Countries
China
Contacts
Public ContactFeiling Feng
The Third Affiliated Hospital of Naval Medical University
Outcome results
None listed