NCT06038461 An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
| NCT ID | NCT06038461 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Neuroendocrine Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2026-09-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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
Inclusion Criteria: * 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; * ECOG performance status: 0-2(determined by investigator); * Expected survival time \> 3 months; * Adequate hepatic, renal, heart, and hematologic functions; * Urine protein \< ++ . If Urine protein ≥ ++ ,the amount of urine protein in 24 hours ≤1.0g; * Before the first dose, serum HCG examination of potential childbearing-women must be negative; Men/Women of childbearing potential must agree to use a highly effective contraceptive method (such as double barrier contraceptive method, condom, oral or injectable contraceptives and intrauterine device) throughout treatment and for at least 90 days after study completion. Exclusion Criteria: * Neuroendocrine cancer, adenocarcino