Phase II Study of TQB2868 Injection with Anlotinib Capsules and Chemotherapy for First-Line Treatment of Metastatic Pancreatic Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a combination treatment including TQB2868 injection, anlotinib capsules, and chemotherapy in patients with metastatic pancreatic neoplasms. This phase II clinical study focuses on patients newly diagnosed with pancreatic ductal adenocarcinoma who have not received prior systemic anti-tumor therapy, aiming to assess this combined approach as a first-line treatment option. The treatment involves two study groups one receiving TQB2868 injection combined with gemcitabine and albumin paclitaxel injections plus oral anlotinib capsules, and the other receiving TQB2868 injection combined with gemcitabine and albumin paclitaxel injections without anlotinib. Treatments are given in cycles of 28 days during the initial treatment period, followed by a maintenance period with cycles of 21 days, while anlotinib is taken orally once daily for two weeks followed by a one-week break. Participants will be monitored regularly through evaluations every eight weeks to measure progression-free survival and other outcomes such as response rate, overall survival, and adverse events. Blood samples will be collected at specified times to analyze drug concentration and immune response. The study includes safety assessments throughout and plans to continue until November 2026, with detailed pharmacokinetic and immunogenicity testing during treatment cycles.

Clinical Study of TQB2868 Injection Combined With Anlotinib Capsule and Chemotherapy in the First-line Treatment of Metastatic Pancreatic Neoplasms