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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06038461
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors

Arms & Interventions

Arms

Experimental: Surufatinib Combined With Temozolomide and S-1

Patients will receive surufatinib combined with temozolomide and S-1 once every three weeks as the second-line treatment until disease progression or intolerable toxicity or patients withdrawal of consent. Phase I: DLTs of surufatinib combined with temozolomide and S-1 will be evaluated based on NCI CTCAE v 5.0 in the first cycle.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Address

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing, 100021

Site Contact

Yihebali Chi, doctor

[email protected]

010-67781331

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