Cancer Clinical Trial
Official title:
An Open-Labeled, Phase I Study to Evaluate the Safety and Tolerability of Apatinib With Nivolumab in Patients With Unresectable or Metastatic Cancer
This is an open-labeled, single-center, Phase I study to evaluate the safety, tolerability, and efficacy of apatinib with nivolumab treatment in participants with unresectable or metastatic cancer. Total study duration will be approximately 50 months: 12 months of recruitment plus 6 months of treatment and subsequent survival follow up.
Primary objectives: - To evaluate the safety and tolerability of apatinib with nivolumab in participants with unresectable or metastatic cancer. - To assess efficacy by objective response rate (ORR), best overall response (BOR), time to response (TTR), and duration of response (DoR) per response evaluation criteria for solid tumors (RECIST) v1.1 and/or response evaluation criteria for solid tumors for immune-based therapeutics (iRECIST). - To assess disease control rate (DCR), and duration of disease control (DDC) by RECIST v1.1, and/or iRECIST. Secondary objectives: - To evaluate the efficacy of apatinib with nivolumab in participants with unresectable or metastatic cancer as measured by: - Overall survival (OS) - Progression-free survival (PFS) - Event-free survival (EFS) ;
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