A Randomized, Controlled, Multi-center Phase III Clinical Study of Ivonescimab Plus Chemotherapy With or Without AK117 Versus Placebo Combined With Chemotherapy as First-line Treatment for Metastatic Pancreatic Cancer
This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.
• Voluntarily sign a written informed consent form.
• Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 3 months.
• Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
• No prior systemic anti-cancer treatment for metastatic PDAC.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate organ function.