This is a prospective, open, single-center study evaluating the efficacy and safety of surufatinib Combined With Temozolomide and S-1 as the first-line treatment of advanced neuroendocrine tumors
Aged 18-75years (inclusive);
Histopathologically confirmed diagnosis of advanced MGMT0/1+ (G1, G2 or G3) neuroendocrine tumor (locally advanced, unresectable or distant metastasis);
Previously untreated with systemic therapy;
Have at least one measurable lesion according to RECIST v1.1;
Neuroendocrine cancer, adenocarcinoid, goblet cell carcinoid,
Functional NETs which need to control symptoms by long-acting somatostatin analogues;
Received a major surgery which requires at least 3 weeks after recovery time, to undergo surgery on treatment of this research within 4 weeks prior to treatment;
Have uncontrolled hypertension, defined as systolic blood pressure >140 mmHg or diastolic blood pressure >90 mm Hg, while under anti-hypertension treatment;
Single group
Surufatinib Combined With Temozolomide and S-1
DrugPhase I: Surufatinib: 250mg, QD, PO, Q3W; Temozolomide: 200-300mg, d10-d14, QD, PO, Q3W; S-1: 40-60mg, d1-d14, BID, PO, Q3W. Phase II: Surufatinib, Temozolomide and S-1：RP2D
Objective response rate (ORR)
the proportion of patients with complete response or partial response, using RESIST v1.1
Progression-Free Survival (PFS)
time from first-dose to the first documented disease progression or death
Disease Control Rate (DCR)
the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1
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