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

NCT07780539 | Not Yet Recruiting

• 1 other identifier: HMPL-012-RWS-BASKET101
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine (NE) Tumors

Outcome Measures

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.

  approximately up to 24 months

Secondary Outcomes (1)

• Objective response rate (ORR)

  approximately up to 24 months

Study Arms (1)

surufatinib

Surufatinib therapy

Drug: Surufatinib Administration

Interventions

Surufatinib Administration DRUG

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

surufatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Advanced neuroendocrine tumor

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yefeng: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Feng Ye

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Ye

CONTACT

+86-592-2137569; yefengdoctor@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Affiliated Hospital of Xiamen University

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): August 31, 2031
• Last Updated: August 21, 2026

Record last verified: 2026-08

Locations

CN (1)