Hepatic metastasis of pancreatic ductal adenocarcinoma
Conditions
Interventions
Intervention group:Camrelizumab + Gemcitabine + albumin bound paclitaxel
Control group:Gemcitabine + albumin bound paclitaxel
Sponsors
The First Affiliated Hospital of Naval Medical University, Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Pancreatic ductal adenocarcinoma with liver metastasis confirmed by histology or cytology may have local lymph node metastasis or other distant metastasis; 3. Patient has never received systematic anticancer treatment; 4. According to the efficacy evaluation criteria of solid tumors (RECIST 1.1), there should be at least one lesion measurable by CT or MRI, and has never received local treatment such as radiotherapy (if the progress is confirmed, the lesion located in the previous radiotherapy area can also be selected as the target lesion); 5. ECOG 0-1; 6. Expected survival >= 12 weeks; 7. All screening period laboratory tests should be carried out according to the protocol requirements, and should be carried out within 14 days before enrollment. The value of laboratory examination for screening must meet the following standards (any blood, growth factor, leukocyte promoting drug, platelet promoting drug and anemia drug must be prohibited within 14 days before the first use of experimental drug): (1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (2) Platelet >= 85 x 10^9/L; (3) Hemoglobin >= 90 g/L; (4) Serum albumin >= 30 g/L; (5) Total bilirubin 60 ml/min; (7) Activated partial thromboplastin time and international standardized ratio <= 1.5 x ULN (patients who can choose to use stabilizer amount anticoagulant therapy, such as low molecular weight heparin or warfarin, INR is within the expected range of anticoagulant); 8. Male and female subjects with potential fertility must agree to use effective contraceptive methods throughout the study period; 9. The subjects voluntarily joined the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with central nervous system metastasis; 2. The patient had only locally advanced disease; 3. Pleural, pericardial or abdominal effusion is uncontrolled and needs drainage; 4. Patients with a history of allergy to monoclonal antibodies, PD-1 antibodies, albumin, paclitaxel and gemcitabine; 5. Within 4 weeks before we first received the experimental drug, the patient had received any experimental drug; 6. In addition to observational clinical trials (non interventional therapy) or follow-up of interventional clinical trials, patients participated in another clinical trial; 7. The patient received the last dose of anticancer treatment (including radiotherapy) within 4 weeks before receiving the first dose of experimental drug; 8. Patients who need corticosteroids or other immunosuppressants; 9. Patients who had received anti-cancer vaccine or had received live vaccine within 4 weeks before the first administration; 10. Patients who underwent major surgery within 4 weeks before the first administration; 11. Patients with active autoimmune disease, autoimmune history; 12. History of immunodeficiency, including HIV positive test or other acquired congenital immunodeficiency diseases, or history of organ transplantation and allogeneic bone marrow transplantation; 13. Patients with uncontrolled cardiovascular clinical symptoms or diseases; 14. Severe infection occurred within 4 weeks before the initial administration; 15. History of interstitial lung disease and non infectious pneumonia; 16. Patients with active pulmonary tuberculosis (APTB) infection confirmed by medical history or CT examination; 17. Patients with active hepatitis B or C; 18. Patients diagnosed with other malignant tumors within 5 years before the first administration; 19. Pregnant or lactating women; 20. As assessed by the researchers, there are other factors that may force participants to end the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OS(Overall Survival); | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(Objective Response Rate);PFS(Progress-Free Survival);DCR(Disease Control Rate); | — |
Countries
China
Contacts
Public ContactLi Gang
Shanghai Changhai Hospital
Outcome results
None listed