This is a single-center, open-label, exploratory study aims to assess the efficacy and safety of QL1706 plus nab-paclitaxel and gemcitabine as first-line treatment for patients with metastatic pancreatic adenocarcinoma.
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Age ≥18 years and ≤ 75 years, ale or Female
Histologically or cytologically confirmed diagnosis of pancreatic cancer (originating from the pancreatic ductal epithelium), with clinical records showing metastatic pancreatic cancer (stage IV according to the AJCC 8th edition TNM staging of pancreatic cancer)
No prior anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.) received
Inability to comply with the study protocol or procedures
patients with pancreatic cancer originating from non-pancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, pancreatic follicular cell carcinoma, pancreatoblastoma, and solid-pseudopapillary tumors
Known presence of germline BRCA1/2 mutations
patients with known central nervous system metastases
Single group
QL1706
Drug5mg/kg, q3w
Chidamide
Drug20mg, biw, q3w
Gemcitabine
Drug1000mg/m2 Q3W
Nab-paclitaxel
Drug125mg/m2 Q3W
ORR
overall response rate
OS
OS is defined as the time from date of treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
AEs
Defined as the proportion of patients with AE, treatment-related AE (TRAE), immune-related AE (irAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Progression-free Survival (PFS)
PFS was assessed by investigators per RECIST 1.1
Disease Control Rate (DCR)
DCR was assessed by investigators per RECIST 1.1
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