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NCT Number: NCT07780539

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surufatinib Administration

Drug

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 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 outcomes

  1. Objective response rate (ORR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Yefeng

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Aug 21, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.