A Single-Arm, Multicenter, Open, Phase II Clinical Study of Adebrelimab and Chidamide in Combination With Gemcitabine and S1 for the First-Line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Pancreatic cancer is a kind of digestive system tumor with high malignant degree and poor prognosis. Most patients with pancreatic cancer are locally advanced or have distant metastases at the time of diagnosis, so it is extremely important to find effective drugs to control tumor metastasis. The primary treatment regimen for advanced pancreatic cancer remains chemotherapy, which results in a median survival time of only 8 to 12 months. Therefore, there is an urgent need to explore new combination therapies to extend survival. Therefore, this study aims to evaluate the efficacy and safety of Adebrelimab and Chidamide in Combination with Gemcitabine and S1 as first-line treatment for locally advanced or metastatic pancreatic cancer.
• 18 to 75 years old;
• Histologically or cytologically confirmed pancreatic cancer (originating from the ductal epithelium of the pancreas) with clinically documented unresectable locally advanced or metastatic pancreatic cancer (stage III/IV according to the TNM stage of AJCC 8 pancreatic cancer);
• have not previously received systematic antitumor therapy for the current stage of disease, including surgery (except stent placement), radiotherapy, chemotherapy, targeting, immunotherapy or investigational therapy;
• There must be at least one measurable lesion as a target lesion (according to RECIST v1.1 standards);
• ECOG(American Eastern Cancer Collaboration) Physical status score: 0\
‣ 1;
• Expected survival ≥3 months;
• The function of major organs is good (no blood components, cell growth factors, whitening drugs, platelet drugs, anemia correction drugs are allowed within 14 days before enrollment);
• Women of childbearing age must have had a blood pregnancy test within 7 days prior to enrollment, with a negative result, and be willing to use an appropriate method of contraception during the trial period and for 6 months after the end of treatment. For men, they should be surgically sterilized or agree to use an appropriate method of contraception during the study period and for 3 months after the end of treatment;
• Voluntarily participate in the study and sign the informed consent;
⁃ Good compliance, agreed to cooperate with the survival follow-up.