Neuroendocrine (NE) Tumors
Conditions
Brief summary
Prior clinical trials have demonstrated promising efficacy and manageable safety of surufatinib in neuroendocrine tumors (NETs). This real-world study aims to evaluate the clinical efficacy and safety of surufatinib in patients with NETs, providing additional real-world evidence to support clinical application, guide novel therapeutic strategies, and ultimately improve patient outcomes.
Interventions
Surufatinib as monotherapy or combination therapy, at the discretion of the investigator based on the patient's overall condition.
Sponsors
Yefeng
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with pathologically or cytologically confirmed neuroendocrine tumors; * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; * Life expectancy ≥ 12 weeks; * Adequate organ and bone marrow function
Exclusion criteria
* Participation in other drug clinical trials with investigational drug treatment within the past 4 weeks; * History of other malignancies within the past 5 years, except for curatively resected basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ; * Patients with contraindications to surufatinib (e.g., active bleeding, ulcer, intestinal perforation, intestinal obstruction, medically uncontrolled hypertension, grade III-IV cardiac dysfunction, within 30 days after major surgery, severe hepatic or renal impairment, etc.); * Presence of any disease or condition that affects drug absorption, or inability to take surufatinib orally; * Any condition deemed by the investigator as unsuitable for study drug treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | approximately up to 24 months | the time from the date of first study treatment to the date of first documented tumor progression (assessed according to RECIST version 1.1) or death due to any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | approximately up to 24 months | the proportion of patients with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria in the analysis population. |
Countries
China
Contacts
CONTACTFeng Ye
PRINCIPAL_INVESTIGATORFeng Ye
The First Affiliated Hospital of Xiamen University
Outcome results
None listed