Real-World Study of the Safety and Efficacy of Surufatinib in the Treatment of Neuroendocrine Tumors

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorYefeng

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial population

Advanced neuroendocrine tumor

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Surufatinib Administration

    Drug

    Surufatinib as monotherapy or combination therapy, at the discretion of the investigator based on the patient's overall condition.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: surufatinib1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

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.

Time frame
approximately up to 24 months

Secondary outcomes

1

Objective response rate (ORR)

the proportion of patients with complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria in the analysis population.

Time frame
approximately up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yefeng

Lead sponsor

The First Affiliated Hospital of Xiamen University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: