Study design and participants
tumor
MAY, TUMOR
A single-center, single-arm, open-label, phase 2 study was designed to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and GEMOX chemotherapy as first-line therapy for unresectable and metastatic ICC in Zhongshan Hospital. Forty-two candidates were screened, and 30 eligible subjects were enrolled in this trial from May 15, 2019, to October 24, 2019 (Fig. GEMOX chemotherapy is a common therapeutic schedule for advanced BTC, including ICC. The safety of combination treatment of lenvatinib with anti-PD1 antibody for patients with advanced ICC was acceptable.The research protocol was approved by the Zhongshan Hospital review board and independent ethics committees (B2019-078R) and was conducted following the Declaration of Helsinki and Good Clinical Practice Guidelines. Each subject was required to sign the informed consent form before enrollment. WES of DNA from fresh biopsy tumor tissues was performed as reported,