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

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06038461

Enrollment

Registered

2023-09-14

Start date

2023-09-15

Completion date

2028-09-15

Last updated

2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Tumors

Keywords

Surufatinib, Temozolomide and S-1, First-line treatment

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

Interventions

DRUGSurufatinib Combined With Temozolomide and S-1

Phase 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Surufatinib Combined With Temozolomide and S-1

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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, 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; * Patients with active ulcer, intestinal perforation and intestinal obstruction; * With active bleeding or bleeding tendency; * Severe history of cardiovascular and cerebrovascular diseases; * Other malignancies diagnosed within the previous 5 years, except basal cell carcinoma or cervical carcinoma in situ after radical resection.

Design outcomes

Primary

Measure	Time frame	Description
Objective response rate (ORR)	approximately 1 years	the proportion of patients with complete response or partial response, using RESIST v1.1

Secondary

Measure	Time frame	Description
Progression-Free Survival (PFS)	approximately 1 years	time from first-dose to the first documented disease progression or death
Disease Control Rate (DCR)	approximately 1 years	the proportion of patients with complete response, partial response or stable disease, using RESIST v1.1

Countries

China

Contacts

CONTACTYihebali Chi, PhD

yihebalichi@hotmail.com010-67781331

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026