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

Neuroendocrine Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06038461
• Other study ID #: HMPL-012-SPRING-NEN106
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 15, 2023
• Est. completion date: September 15, 2026

Study information

• Verified date: September 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Yihebali Chi, PhD
• Phone: 010-67781331
• Email: yihebalichi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 15, 2026
• Est. primary completion date: September 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

Drug:
• Surufatinib 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

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

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