Malignant tumors of the biliary tract (including gallbladder cancer, hilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, and distal cholangiocarcinoma)
Conditions
Interventions
Intervention Group:NGS and AI analysis informs the clinical management plan
Sponsors
Tongji Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Provide written informed consent and agree to comply with all protocol requirements before undergoing any study procedures; 2.Participants are generally aged between 18 and 80 years, with an ECOG score of 0–2; 3.Life expectancy >= 3 months; 4.Histologically confirmed biliary tract cancer (including gallbladder cancer, hilar cholangiocarcinoma, intrahepatic cholangiocarcinoma, and distal common bile duct cancer) that has progressed after or been intolerant to at least two prior lines of standard therapy; 5. Measurable lesions according to RECIST v1.1 criteria; 6. Adequate organ and bone marrow function, defined as follows: Hematologic function: Hemoglobin >= 9.0 g/dL, absolute neutrophil count >= 1.5 × 10?/L, platelet count >= 100 × 10?/L; Renal function: Serum creatinine = 45 mL/min; Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 3.0 × ULN (<= 5.0 × ULN in patients with liver metastases), total bilirubin <= 1.5 × ULN; Coagulation function: International normalized ratio (INR) <= 1.5 or prothrombin time <= 1.5 × ULN, activated partial thromboplastin time (APTT) <= 1.5 × ULN.
Exclusion criteria
Exclusion criteria: 1.Patients with poor compliance (due to geographical, familial, social, or psychological reasons, patients are unwilling or unable to adhere to the required medical follow-ups of the trial); 2.Currently participating in another interventional clinical study, or having received other investigational drug treatments within 2 weeks prior to the first dose; 3.Receipt of other antitumor therapies that may interfere with the trial outcomes within 2 weeks prior to the first dose; 4.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; 5.Uncontrolled hypertension, severe cardiovascular diseases, or other severe systemic illnesses; 6.Uncontrolled epilepsy, neurological impairment, or treatment-related severe neurological dysfunction, or poorly controlled psychiatric disorders; 7.Diagnosis of other malignancies within the past 5 years, except for completely resected carcinoma in situ, basal cell carcinoma, or Stage I squamous cell carcinoma; 8.Pregnant or lactating women; 9.Other conditions deemed by the investigator as inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Control Rate, DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of relief,DoR;Overall survival,OS;Progression free survival,PFS;objective response rate,ORR; | — |
Countries
China
Contacts
Public ContactWeifeng Tan
Tongji Hospital of Tongji University
Outcome results
None listed