Sintilimab in the Treatment of Advanced and Refractory Pediatric Malignant Tumors

Summary

This is a single center, single arm, open-label and phase I clinical study. The standard 3 + 3 group design was performed. Patients were enrolled by the design of phase I study standard. Sintilimab was divided into three dose levels: 1 mg / kg, 3 mg / kg, and 10 mg / kg. Dose escalation was carried out from the first level of sintilimab. The study is to evaluate the safety, including dose limited toxicity (DLT) in the treatment of advanced, recurrent, and refractory childhood cancer.

Timeline

Start

2020-08-11

Primary completion

2021-10-10

Completion

2021-12-10

Publications

• Que Y, Wang J, Sun F, Wang S, Zhu J, Huang J, Zhao Z, Zhang L, Liu J, Xu J, Zhen Z, Sun X, Lu S, Zhang Y. Safety and clinical efficacy of sintilimab (anti-PD-1) in pediatric patients with advanced or recurrent malignancies in a phase I study. Signal Transduct Target Ther. 2023 Oct 13;8(1):392. doi: 10.1038/s41392-023-01636-9.

Drugs

Indications