Biliary tract tumors
Conditions
Interventions
Experimental group:Gemcitabine 1000mg/m2, cisplatin 25mg/m2, D1,8, Q3W + donafenib 200mg bid, continuous taking + tislelizub 200mg, Q3W chemotherapy for up to 8 cycles, if still inoperable, switch to
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, signed written informed consent; 2. Age 18~75 years old (including cut-off value), male or female; 3. Histologically confirmed potentially resectable locally advanced biliary tract malignant tumors (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, gallbladder cancer, ampullary carcinoma); Potentially resectable criteria: R0 resection cannot be guaranteed and one or more of the following imaging features are present: hilar and retroperitoneal lymph nodes are considered metastatic but can be radically resected; Intrahepatic cholangiocarcinoma with intrahepatic contralateral metastases or invasion of the remaining hepatic vein or portal vein; local progression of gallbladder cancer with colon or duodenal involvement; hilar cholangiocarcinoma or the lower segment of cholangiocarcinoma involving the portal vein or hepatic artery requiring combined vascularization or reconstruction; 4. No anti-tumor therapy; 5. ECOG PS score of 0-1; 6. Presence of at least 1 measurable lesion according to RECIST1.1 criteria in CT/MRI; 7. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the past 14 days, the absolute neutrophil value (ANC) = 1.5x109/L; 2) In the case of no blood transfusion in the past 14 days, platelet = 75×109/L; 3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 90g/L; 4) total bilirubin =3× upper limit of normal (ULN); 5) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at =5× ULN; 6) serum creatinine =1.5×ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) = 60 ml/min; 7) good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) = 1.5 times ULN; 8) Serum albumin=30g/L; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 8. Women of childbearing potential should have a negative serum or urine pregnancy test within 3 days prior to inclusion in the study and must be a non-lactating woman, and the patient should agree to use contraceptives (such as intrauterine devices, contraceptives, or condoms) for the duration of the study and for at least 5 months after the end of the study period; 9. Males with partners of childbearing potential should agree to use contraceptives for the duration of the study and for 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Previous treatment of systemic therapies such as other chemotherapy drugs, targeted drugs, PD-1 antibodies, etc., which the investigator believes will have an impact on the research results; 2. Other malignant tumors in the past 5 years; 3. Active or uncontrolled severe infection (e CTCAE grade 2 infection); 4. Diagnosis of non-biliary tract cancer components such as hepatocellular carcinoma, mixed cell carcinoma or fibrolamellar cell carcinoma; 5. Current participation in interventional clinical study treatment, or treatment with other investigational drugs or investigational devices within 4 weeks prior to the first dose; 6. Suffering from diseases that affect the absorption, distribution, metabolism, or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.); 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Has any active autoimmune disease or history of autoimmune disease; 9. Patients with congenital or acquired immunodeficiency (such as HIV infection); 10. Subject is receiving immunosuppressants, or systemic or absorbable topical hormonal therapy for immunosuppressive purposes, and continues to receive such therapy within 2 weeks prior to enrollment; 11. Those who are known to be allergic to the active ingredients or excipients of gemcitabine, cisplatin, tislelizumab and donafenib of this study drug; 12. Abnormal medical history or evidence of disease, treatment or laboratory test values that may interfere with the results of the trial, prevent the subject from participating in the study throughout the study, or other potential risks that the investigator considers unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor imaging evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood biochemistry;Complete blood count;Urinalysis; | — |
Countries
china
Contacts
Public ContactWenyan Jin
West China Hospital of Sichuan University
Outcome results
None listed