Recruiting NCT06038461
An Open, Single-center Clinical Study of Surufatinib Combined With Temozolomide and S-1 in the First-line Treatment of Advanced Neuroendocrine Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Surufatinib Combined With Temozolomide and S-1.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
Primary outcome measures
- Objective response rate (ORR) [Time frame: approximately 1 years]
Secondary outcome measures (2)
- Progression-Free Survival (PFS) [Time frame: approximately 1 years]
- Disease Control Rate (DCR) [Time frame: approximately 1 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT06038461 · HMPL-012-SPRING-NEN106