An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Surufatinib Combined With Temozolomide and S-1

Treatment groups

40 Participants
are divided into 1 treatment group