NCT07235930
Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer
Recruiting · Phase 3 · Zhejiang Cancer Hospital · registry updated 2025-11-19
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
- Measurable lesions at baseline according to RECIST 1.1 criteria; if the subject has only 1 measurable lesion at baseline, the area of the lesion must not have received radiotherapy in the past or there must be evidence of significant progression of the lesion after completion of radiotherapy treatment;
- the ECOG physical status score was 0 or 1 and the Expected survival ≥12 weeks;
Exclusion
- 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;
- previous treatment with vascular endothelial growth factor (VEGFR) inhibitors or previous treatment with immune checkpoint inhibitors;
- antitumor treatment with chemotherapy, small molecule inhibitors, immunotherapy (e.g., interleukin, interferon, or thymosin) within 28 days prior to enrollment in this study, and herbal medicine with antitumor indications within 14 days prior to dosing;