Unresectable advanced biliary tumor
Conditions
Interventions
Cryoablation, Trifluridine-tipiracil, GC chemotherapy:Cryoablation, Trifluridine-tipiracil, GC chemotherapy
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Obtain written informed consent before implementing any trial-related procedures; 2.Age 18-75 years, any gender; 3.Histologically or cytologically confirmed malignant biliary tumor (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma, and gallbladder cancer); 4.No prior systemic therapy and having unresectable locally advanced or metastatic disease (patients who relapse more than 6 months after completing adjuvant therapy are allowed to enroll); 5.At least one measurable lesion according to RECIST 1.1 criteria; 6.Tumor maximum diameter 3 months. 9. Adequate organ function: participants need to meet the following lab criteria: (1) Absolute neutrophil count >= 1.5 × 10^9/L; (2) Platelets >= 80 × 10^9/L; (3) Total bilirubin = 60 mL/min; (6) Good coagulation function, defined as INR or PT <= 1.5 × ULN. 10. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days before the trial starts. 11. Participants are willing and able to follow the study protocol during the trial, including receiving treatment, adhering to contraception, and attending regular visits and check-ups (including follow-up).
Exclusion criteria
Exclusion criteria: 1.Diagnosis of malignancies other than biliary tumors within 5 years prior to first administration (excluding completely resected basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been completely removed). b) Previous treatment with any of the following: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). c) Previous palliative radiotherapy for biliary tumors, excluding postoperative adjuvant radiotherapy; 2.Previously received the following therapies: anti-PD-1, anti-PD-L, or anti-PD-L2 drugs, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137). 3.Previous palliative radiotherapy for biliary tract tumors, excluding postoperative adjuvant radiotherapy; 4.Patients who cannot tolerate percutaneous argon-helium cryoablation; 5.Presence of immunodeficiency diseases or HIV infection; 6.Severe uncontrolled acute infection (fever =38°C due to infection); 7.Active hepatitis B or hepatitis C infection, with hepatitis B virus (HBV) DNA titer =2000 IU/mL (or 1×10^4 copies/mL), or hepatitis C virus (HCV) RNA = lower limit of detection; 8.Severe liver or kidney dysfunction, or recent myocardial infarction (within 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR;Objective response rate, ORR; | — |
Countries
China
Contacts
Public ContactFu-Yu Li
West China Hospital of Sichuan University
Outcome results
None listed