Histologically confirmed, unresectable advanced biliary tract tumors, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder cancer (diagnosed according to the criteria outlined in the 2025 CSCO Guidelines for Diagnosis and Treatment of Malignant Biliary Tumors, and confirmed through multidisciplinary discussion)
Conditions
Interventions
Precision Treatment Based on Molecular Subtyping (or Gene Mutations):Targeted drugs or immunotherapies for cholangiocarcinoma based on targetable gene mutations
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 and = 10 mm on Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) scan). 4.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5.Child-Pugh class A or B liver function. For patients with obstructive jaundice, total bilirubin must be 50 µmol/L. 6.Adequate hematologic function: Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L, Hemoglobin (Hb) >= 8.5 g/L, Platelets (PLT) >= 75 × 10^9/L. 7.No history of severe arrhythmia or heart failure; no severe ventilation dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance > 40 mL/min. 8.Life expectancy of more than 3 months.
Exclusion criteria
Exclusion criteria: 1.Major surgery within 28 days prior to enrollment. 2.Presence of any unresolved toxicity of Grade >= 2 (according to Common Terminology Criteria for Adverse Events [CTCAE] v4.0) from prior anticancer therapy at the time of enrollment, with the exception of alopecia or Grade 2 anemia. 3.Known hypersensitivity to any components or excipients of the study drugs. 4.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence. Patients currently receiving immunosuppressants or systemic corticosteroids for immunosuppressive purposes. 5.Presence of other concurrent malignancies. 6.Presence of brain metastases or spinal cord compression. 7.Presence of any severe and/or unstable pre-existing medical conditions, mental illness, or other conditions that could compromise patient safety, the ability to provide informed consent, or adherence to the study procedures. 8.Pregnant or breastfeeding women. 9.History of organ transplantation. 10.Patients with proteinuria >= 1+ on urinalysis must undergo a 24-hour urine protein test. Patients with a 24-hour urine protein level >= 1g are excluded. 11.Clinically significant corneal or retinal disease confirmed by ophthalmologic examination. 12.Liver tumor burden exceeding 50%. 13.Hypothyroidism or hyperthyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Disease control rate, DCR;Conversion Resection Rate, CRR;Progression-free survival, PFS;Treatment-related adverse events, TRAEs treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactYan Maolin
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed