Combining Surufatinib with Temozolomide and S-1 for treating advanced neuroendocrine tumors

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

This study is testing a new combination of three medications to see if it can help people with advanced neuroendocrine tumors who haven't had treatment before.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: surufatinib
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06038461 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of a combination treatment involving surufatinib, temozolomide, and S-1 as a first-line therapy for patients with advanced neuroendocrine tumors. It is a prospective, open-label, single-center study that aims to enroll patients who have not previously received systemic therapy for their condition. Participants will be monitored for measurable lesions and overall health status throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with histopathologically confirmed advanced neuroendocrine tumors who have not received prior systemic therapy.

Not a fit: Patients with neuroendocrine cancer that is adenocarcinoma or those who have received previous systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced neuroendocrine tumors.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches in treating neuroendocrine tumors have shown promise in other studies.

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, 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.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yihebali Chi, PhD

Conditions Neuroendocrine Tumors; Surufatinib; Temozolomide and S-1; First-line treatment