Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untrea… (NCT06393166) | Clinical Trial Compass
UnknownPhase 2
Sequential AG and mFOLFOX Combined With Serplulimab Injection and Bevacizumab Injection in Untreated Advanced Pancreatic Cancer
China37 participantsStarted 2023-05-01
Plain-language summary
It is a single arm, open-label, multicenter, phase II cinical trial to evaluate the efficacy and safety of the Sequential AG and mFOLFOX in Combination With Serplulimab Injection and Bevacizumab Injection in first-line treatment of patients with Advanced or Metastatic Pancreatic Cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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;
✓. No serious organic diseases of the heart, lungs, brain and other organs;
✓. Adequate organ function
Exclusion criteria
✕. 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;
✕. major surgical procedures \[such as transabdominal, transthoracic and other major surgeries; excluding diagnostic puncture such as ultrasonic endoscopy-guided pancreatic fine-needle aspiration biopsy (EUS-FNB), percutaneous hepatic perforation biopsy, peripheral venous catheterization, and biliary stent implantation\] or invasive treatments or operations with incomplete healing of the surgical incision, local anti-tumor treatment such as hepatic artery interventional embolization, hepatic metastasis cryo-ablation, radiofrequency ablation and other local anti-tumor treatments. radiofrequency ablation and other local antitumor therapy;
✕. have received radical radiotherapy within 3 months prior to study entry; palliative radiotherapy 2 weeks prior to dosing is permitted, and the dose of radiotherapy meets local standards of care for palliative care;