Patients with unresectable or metastatic biliary tract cancer, including those who progressed after surgery, and who have not received prior systemic treatment.
Conditions
Interventions
Standard treatment control group:GP+PD-1/PD-L1
Bortezomib group:Bortezomib
Sponsors
Thrid Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed biliary tract cancer (BTC). 2. Measurable disease as per RECIST 1.1 criteria. 3. WHO/ECOG performance status of 0-2. 4. Unresectable or metastatic disease, with no prior systemic therapy. 5. Adequate hematological function: White blood cell count > 3.0 × 10?/L, Platelet count > 100 × 10?/L. 6. Adequate hepatic function: Total bilirubin 60 mL/min and/or Serum creatinine < 120 µmol/L. 8. No cardiac insufficiency or uncontrolled chest pain. No history of myocardial infarction within 12 months prior to study initiation; 9. Signed informed consent form. 10. Age range from 18 to 75 years old.
Exclusion criteria
Exclusion criteria: 1. Presence of a concurrent secondary or other active malignancy within 3 years prior to study initiation. 2.Presence of brain or leptomeningeal metastases. 3. Contraindications to bortezomib. 4. Chronic diarrhea or inflammatory bowel disease, or untreated/insufficiently managed intestinal obstruction or sub-obstruction that may affect systemic drug administration. 5. Active infection or other severe, uncontrolled infection that may impede the planned treatment. This includes long-term, uncontrolled bacterial cholangitis due to biliary stent obstruction, two or more episodes of cholangitis within the past 6 months, other active infections, uncontrolled severe infections, cirrhosis, or chronic active hepatitis. 6. Cardiac insufficiency, unstable angina, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, or severe, uncontrolled cardiac arrhythmias. 7. Concurrent participation in another clinical trial. 8. Pregnant or lactating women. 9. Received chemotherapy or radiotherapy within 1 month prior to the study, or is currently receiving such treatments. 10. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival ;Objective relief rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactZhengang Yuan
Thrid Affiliated Hospital of Naval Medical University
Outcome results
None listed