Pancreatic cancer with liver metastases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >=18 and =3 months; 7. Adequate organ function, including: (1) Hemoglobin (Hb) >=90 g/L; (2) Absolute neutrophil count (ANC) >=1.5 × 10^9/L; (3) Platelet count (PLT) >=50 × 10^9/L; (4) Total bilirubin (TBIL) 60 mL/min; 8. Agreement to use effective contraception during the study period and for 120 days after the last dose, or prior surgical sterilization; 9. Written informed consent signed voluntarily with good protocol compliance anticipated.
Exclusion criteria
Exclusion criteria: 1. Active brain metastases, peritoneal metastases, or bone metastases; 2. Use of immunosuppressive agents within 28 days before first administration; 3. Receipt of antitumor traditional Chinese medicine or immunomodulatory therapy within 4 weeks before first dosing; 4. Severe cardiovascular disease; 5. Severe infection or major surgery within 4 weeks before first administration; 6. Active autoimmune disease or immunodeficiency; 7. Poorly controlled asthma; 8. HIV infection or active hepatitis B/C infection; 9. History of solid organ or hematopoietic stem cell transplantation; 10. Participation in another interventional clinical trial; 11. Known hypersensitivity to the study drug or similar biologics; 12. History of allogeneic organ transplantation; 13. Psychiatric disorders or substance abuse history; 14. Uncontrolled hypertension; 15. Coagulation dysfunction or bleeding tendency; 16. Urine protein >=++ or 24-hour urinary protein >=1.0 g; 17. Any other condition deemed unsuitable for study participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College