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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Yihebali Chi, PhD
• Email: yihebalichi@hotmail.com
• Phone: 010-67781331

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.