Patients with recurrent or metastatic biliary tract malignancies that are refractory to at least one prior lines of standard therapy.
Conditions
Interventions
Test Group :NGS+AI-assisted decision-making
Sponsors
Thrid Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All participants must voluntarily participate in the trial and sign the informed consent form; 2. Participants should generally be aged between 18 and 75 years, male or female, with an ECOG score of 0-2; 3. Participants must have an expected survival time of >= 3 months; 4. Histopathologically or cytologically confirmed unresectable, locally advanced, recurrent, or metastatic biliary tract malignancies; 5. Recurrent or metastatic biliary tract malignancies in patients who have failed or developed resistance to at least one prior lines of standard therapy; 6. During the study period and for 6 months after the last dose, subjects of childbearing potential (both male and female) must use effective medically approved contraception. For female subjects of childbearing potential, a negative pregnancy test must be confirmed within 72 hours before the first dose; 7. Adequate organ and bone marrow function, defined as follows: Blood Routine Tests: * Neutrophil count (NEU#) >=1.0×10^9/L * Platelet count (PLT) >=80×10^9/L * Hemoglobin >=90 g/L Liver Function: * For subjects without liver metastases: * Aspartate aminotransferase (AST) =50 mL/min Coagulation Function: * International normalized ratio (INR) <=1.5 × ULN * Activated partial thromboplastin time (APTT) =1.5 × ULN;
Exclusion criteria
Exclusion criteria: 1. Patients with poor compliance; 2. Patients with severe hematopoietic dysfunction, or abnormal cardiac, pulmonary, hepatic, or renal function, or immunodeficiency; 3. Patients currently participating in another interventional clinical study, or having received other investigational drug therapy within 2 weeks prior to the first dose; 4. Patients who have received other anti-tumor therapies that may influence the trial outcomes within 2 weeks prior to the first dose; 5. Patients with a history of severe arterial/venous thrombotic events within 6 months prior to the first dose, including cerebrovascular accident (stroke or intracranial hemorrhage), deep vein thrombosis, and pulmonary embolism; 6. Patients with uncontrolled hypertension, severe cardiovascular disease, or other severe systemic diseases; 7. Patients with uncontrolled epilepsy, neurological failure, or treatment-related severe neurological impairment, or those with uncontrollable psychiatric disorders; 8. Patients with two or more primary malignancies within 5 years prior to the first dose or at present, except for clinically cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically resected; 9. Pregnant or lactating women; 10. Other conditions deemed by the investigator as inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival ,OS;Progression-Free Survival, PFS;Disease Control Rate ,DCR; | — |
Countries
China
Contacts
Public ContactZhengang Yuan
Thrid Affiliated Hospital of Naval Medical University
Outcome results
None listed