Pancreatic cancer
Conditions
Interventions
1:(albumin-bound) paclitaxel + gemcitabine
2:Anlotinib hydrochloride + Tirellizumab + (albumin-bound) paclitaxel + gemcitabine
Sponsors
Second Hospital of Lanzhou University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age: 18-75 years old, male or female. 2) Histologically or cytologically confirmed pancreatic cancer. 3) Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. 4) Newly obtained or archived tumor tissue samples can be provided. 5) ECOG 0-1. 6) Life expectancy greater than 12 weeks. 7) Organ function is sufficient. 8) The patient has given written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients who have received or are receiving additional chemotherapy, radiation therapy, targeted therapy, or immunotherapy. 2) Other malignancies within 5 years prior to study entry, basal cell carcinoma of the skin and squamous cell carcinoma for which curative treatment is expected and/or in situ cervical cancer and/or breast cancer for which curative resection is expected. 3) Known central nervous system (CNS) metastases. 4) Subjects with any active autoimmune disease or history of autoimmune disease. 5) Uncontrolled clinically significant heart disease, including but not limited to: ? > NYHA II congestive heart failure; ? Unstable angina pectoris; ? Myocardial infarction within the past 1 year; ? Clinically significant supraventricular arrhythmia or ventricular arrhythmias requiring treatment or intervention. 6) Active infection or unexplained fever >38.5°C during screening or before the first day of scheduled dosing (subjects with tumor fever can be included at the discretion of the investigator). 7) History of interstitial pneumonia or active non-infectious pneumonia. 8) Known human immunodeficiency virus (HIV) infection, active hepatitis B or C. 9) Previous treatment with anti-PD-1 drugs. 10) Requires cortisol (>10mg/d prednisone or equivalent dose) or other system within 14 days prior to study treatment. Concurrent medical conditions with sexual immunosuppressive drugs. Except: inhaled or topical corticosteroids. Dose > 10 mg/d prednisone or equivalent replacement therapy. 11) Received prior anti-cancer monoclonal antibody, chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study day 1, or did not recover from an adverse event due to previously administered drugs. 12) Received a live vaccine within 4 weeks of the first dose of study drug. 13) Pregnant or breastfeeding. Decisions of inappropriate inclusion were made by the principal investigator or the physician in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;Quality of life, QoL; | — |
Countries
China
Contacts
Public ContactChen Hao
The Second Hospital of Lanzhou University
Outcome results
None listed