cholangiocarcinoma
Conditions
Interventions
Experimental group:tislelizumab combined with rigofenib and arterial perfusion chemotherapy
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria related to disease: (1) Aged >=18 years; (2) PS score 0-1; (3) Patients with locally advanced or metastatic intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder carcinoma confirmed by histopathology or cytopathology; (4) At least one measurable lesion based on RECIST1.1 criteria; (5) Hematology, Biochemistry and organ function: 1) Blood routine: white blood cell count (WBC) >=3.0x10^9/L, neutrophil absolute count (ANC) >=1.5x10^9/L, platelet count (PLT) >=100x10^9/L, hemoglobin (HGB) >=90 g/L (no blood transfusion or erythropoietin dependence within 7 days); 2) Liver function: total bilirubin (TBIL) =60 mL/min (Cockcroft-Gault formula), and urine protein (UPRO) <2+ or 24 hours urine protein quantitative <1g. 2. General inclusion criteria: (1) Fertile patients must be willing to take highly effective contraception during the study period and for 120 days after the last dose of tirelizumab; (2) It is expected that compliance with the study protocol will be good, that written informed consent (ICF) will be provided, and that the study requirements and evaluation schedule will be understood and agreed to.
Exclusion criteria
Exclusion criteria: 1. The patient had previously received immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy; 2. The patient had previously received radiotherapy, chemotherapy, targeted therapy or interventional therapy (I-particle implantation, ablation, but not PTCD); 3. The patient has autoimmune disease; 4. Received systemic systemic therapy with Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks before the first administration; 5. Allergy to any study drug or excipient; 6. Receiving any other form of immunosuppressive therapy within 7 days prior to initial administration; 7. There was a history of non-infectious pneumonia requiring glucocorticoid therapy or a current interstitial lung disease within 1 year prior to initial administration; 8. An active autoimmune immune disease requiring systemic therapy (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) occurred within 2 years prior to initial administration. Allow the use of alternative therapies (such as thyroxine, insulin, or physical corticosteroids for adrenal or pituitary insufficiency); 9. Untreated active hepatitis B; 10. Patients with active hepatitis C virus (HCV) infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 11. Have received solid organ or blood system transplantation, except corneal transplantation; 12. A known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 13. Received live attenuated vaccine within 4 weeks prior to initial administration (or planned to receive live vaccine during the study period); Note: Inactivated injectable virus vaccine against seasonal influenza is permitted for up to 4 weeks prior to initial administration; But live attenuated flu vaccines are not allowed; 14. Currently participating in the intervention clinical study treatment, or receiving other trial drugs or using trial devices within 4 weeks before the first dose; 15. Large to medium surgery, or unhealed surgical incisions, ulcers, or fractures within 4 weeks prior to initial dosing; 16. Minor surgery (e.g., outpatient/inpatient surgery with local anaesthesia, central venous catheterization) performed within 48 hours prior to initial receipt of the study drug; 17. Aspirin (> 325 mg/ day) or other NSaids known to inhibit platelet function for 10 consecutive days within 2 weeks prior to initial administration; 18. A history of hereditary bleeding or cocoagulation disorder, or thrombosis; 19. Treated uncontrolled hypertension (systolic blood pressure greater than 140 mmHg and/or diastolic blood pressure greater than 90 mmHg), a history of hypertensive crisis or hypertensive encephalopathy; 20. Any unstable systemic disease: These include, but are not limited to, active infections, unstable angina, cerebrovascular accidents or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure [NYHA classification >= ?], severe arrhythmias requiring medication, liver, kidney or metabolic diseases; 21. Patients who are pregnant or breastfeeding or who plan to breastfeed during the study period; 22. Conditions considered unsuitable for inclusion by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Duration of response, DOR;Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactLi Zhen
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed