Phase II Study of Sintilimab, IBI310, and Surufatinib Combination for Treating High-grade Advanced Neuroendocrine Neoplasms

What this Trial Is About

Researchers are evaluating the combination of Sintilimab, IBI310, and Surufatinib in patients with high-grade advanced neuroendocrine neoplasm who have not responded to or cannot tolerate standard treatments. This phase II, single-arm, open-label study aims to assess the treatments safety and how well it works in this population, focusing mainly on the objective response rate. Participants will receive Surufatinib orally once daily at a dose of 250 mg, Sintilimab intravenously at 200 mg every three weeks, and IBI310 intravenously at 1 mgkg every six weeks. Treatment continues until the disease progresses, unacceptable side effects occur, the participant requests to stop, or consent is withdrawn. Sintilimab treatment has a maximum duration of two years. This study is conducted at multiple centers and expects to include around 40 patients. During the study, patients will have regular assessments including physical exams, vital signs checks, laboratory tests, and tumor evaluations based on RECIST 1.1 criteria to monitor response and safety. Researchers will track objective response rates, progression-free survival, duration of response, overall survival, and treatment safety for up to approximately two years. Tumor specimens will also be collected to study PD-L1 expression and immune cell infiltration. Participants health status and adverse events will be closely monitored throughout the trial.

Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC (NESSIE)