Advanced pancreatic cancer
Conditions
Interventions
treatment group:Tislelizumab in combination with gemcitabine and Sega
Sponsors
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Understand the test steps and content, and voluntarily sign a written informed consent; 2. Aged 18-75 years; 3. Patients with pathologically confirmed metastatic pancreatic cancer; 4. Have not received systemic treatment for metastatic disease; 5. Eastern Cooperative Oncology Group (ECOG) physical status (PS) = 1.5x10^9/L [in the absence of granulocyte/granulocyte-macrophage colony-stimulating factor (G-CSF/GM-CSF) or other medically supportive therapy]; platelet >= 100x10^9/L; hemoglobin >= 90g/L (without blood transfusion or medical supportive therapy such as blood cytokines within 14 days); (2) Serum creatinine = 50 mL/min; (3) Serum total bilirubin (STB) 1.0 ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <= 2.5xULN (ALT or AST <= 5xULN is acceptable for liver metastases); (4) International normalized ratio (INR) <= 1.5, and activated partial prothrombin time (aPTT) <= 1.5xULN (unless concurrently receiving anticoagulation therapy).
Exclusion criteria
Exclusion criteria: 1. Suffering from other malignant tumors at the same time, except for malignant tumors that have been cured or have stable disease; 2. Participate in another clinical trial within 28 days before randomization (in the case of a monoclonal antibody trial, within 5 half-lives of the drug), have received active drug treatment, or intend to participate in another clinical trial throughout the study period; 3. Received radiotherapy within 2 weeks before randomization; 4. Those who have undergone major surgery or serious trauma within 28 days before randomization or are expected to need major surgery during the trial (defined as surgery requiring more than 3 weeks of recovery after surgery); 5. There is a clinically significant active infection requiring systemic treatment (NCI CTCAE>2); 6. There are systemic severe or uncontrolled underlying diseases (including dyspnea or severe lung disease at rest, uncontrolled hypertension, metabolic diseases, abnormal wound healing, ulcers or fractures, etc.) or abnormal laboratory tests, which the investigator believes will significantly increase the risk of drug administration of the trial drug, or affect the evaluation of efficacy; 7. Non-hematological toxicity caused by previous treatment is >= 1 grade before randomization (CTCAE 5.0, except for neurotoxicity of = 1 x 10^3 copies/mL or local laboratory methods > the lower limit of quantification; if the HBV-DNA titer detection is less than 1x10^3 copies/mL or the local laboratory method is less than or equal to the lower limit of quantification, the investigator judges that the subjects with chronic hepatitis B are in a stable phase and will not increase the risk of the subjects, they can be enrolled; 10. Long-term oral (including inhaled) glucocorticoids (equivalent to prednisone>10 mg/day); 11. Those who are known to have a history of allergic reactions to test drugs such as tislelizumab, gemcitabine, and Sigirgio or any of their excipients, those who are known to have a history of allergic diseases or have allergic constitution; 12. The researcher believes that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactLiang Jing
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Outcome results
None listed