About this trial
A randomized, multicenter, Phase III trial evaluating the efficacy and safety of first-line Sequential AG-mFOLFOX chemotherapy combined with Serplulimab and Bevacizumab versus AG chemotherapy alone in advanced pancreatic cancer. The primary endpoint is Overall Survival (OS). Approximately 292 patients will be enrolled in China.
Eligibility criteria
Qualifiers
Voluntarily agree to participate in the study and sign the informed consent;
≥18 years of age and ≤75 years of age on the day of signing the informed consent form, regardless of gender;
Pancreatic ductal adenocarcinoma confirmed by pathologic histology or cytology;
No prior systemic therapy for unresectable locally advanced or metastatic pancreatic cancer;
Disqualifiers
subjects with clear brain metastases on imaging or with meningeal metastases;
untreated spinal compression fractures not treated by surgery and/or radiotherapy; treated spinal compression fractures require disease stabilization for at least 2 weeks prior to enrollment;
high risk of gastrointestinal or abdominal bleeding as evaluated by the Investigator;
uncontrolled cancer pain; narcotic analgesics not at a stable dose at enrollment;
Trial design
Treatments tested in this trial
- Sequential AG and mFOLFOX in Combination With Serplulimab and Bevacizumab
- AG chemotherapy