Status:
RECRUITING
An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06038461
Start Date
September 15 2023
End Date
September 15 2026
Last Update
October 1 2024
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021