Study design and participants
tumors
METASTASIS TO THE BRAIN, MAY, CONCOMITANT DISEASE, ONCOLOGY, TUMORS, SECONDARY MALIGNANCIES
This was a single-armed, open-labeled, phase II, prospective study (ChiCTR2000036652), preregistered on 24th Aug, 2020. The study was conducted according to the guidelines dictated by the Helsinki Declaration and international standards of good clinical practice. The Ethics Committee of Eastern Hepatobiliary Surgery Hospital approved the protocol and any protocol amendments. All the enrolled patients provided a written informed consent form. In this study, we enrolled 30 patients with advanced BTC receiving GemCis plus sintilimab between August 2020 and May 2022 in the Shanghai Eastern Hepatobiliary Surgery Hospital. Newly diagnosed 18–75-year-old patients with histologically and cytologically confirmed BTC were eligible for inclusion. Furthermore, patients with at least one measurable lesion as the target lesion according to RECIST V.1.1 and an Eastern Cooperative Oncology Group performance status of 0–2 were eligible for inclusion. The exclusion criteria for the patients were as follows: the presence of secondary malignancies or other types of tumors with metastasis to the brain or meninges within 3 years before study initiation and incidence of concomitant diseases that, in the investigator’s judgment, may seriously endanger their safety or interfere with the completion of the study.