Study design and patients
advanced/metastatic disease, tumour
DISEASE, TUMOUR
This study was a non-randomised, single-arm, first-line prospective multi-centre phase II trial. Patients were included with histologically confirmed and advanced high-grade neuroendocrine neoplasms of gastroenteropancreatic or of unknown origin with a predominance of gastrointestinal metastasis. The study had the following inclusion criteria: WHO performance status of 0–1, tumour Ki-67 index of 21–55%, no previous therapy for advanced/metastatic disease, and measurable disease according to Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v. 1.1).