Neuroendocrine (NE) TumorsNCT07780539
Real-World Study of the Safety and Efficacy of Surufatinib in the Treatment of Neuroendocrine Tumors
An observational study of Neuroendocrine (NE) Tumors, run by Yefeng at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine (NE) Tumors
- What is being tested?
- Surufatinib Administration
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Advanced neuroendocrine tumor
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Feng Ye, +86-592-2137569, yefengdoctor@sina.com
About this study
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
- Being tested
- Surufatinib Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib AdministrationDrug
Surufatinib as monotherapy or combination therapy, at the discretion of the investigator based on the patient's overall condition.
| Study group | Role | What they receive |
|---|---|---|
| surufatinib | Surufatinib therapy Receives: Drug: Surufatinib Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: approximately up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine (NE) TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yefeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yefeng, The First Affiliated Hospital of Xiamen University
- Investigators
- Feng Ye, Principal investigator, The First Affiliated Hospital of Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780539
- Sponsor's protocol ID
- HMPL-012-RWS-BASKET101
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of the Safety and Efficacy of Surufatinib in the Treatment of Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT07780539
- Acronym / sponsor ID
- HMPL-012-RWS-BASKET101
- Conditions
- Neuroendocrine (NE) Tumors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- YefengUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 31 Aug 2031 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surufatinib | – | Drug: Surufatinib AdministrationSurufatinib therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Advanced neuroendocrine tumor
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surufatinib AdministrationSurufatinib as monotherapy or combination therapy, at the discretion of the investigator based on the patient's overall condition. | Drug | surufatinib |
Primary outcome
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.
1 secondary outcome
Objective response rate (ORR)
Time frame: approximately up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Ye principal investigator
The First Affiliated Hospital of Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine (NE) Tumors, run by Yefeng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Ye (+86-592-2137569, yefengdoctor@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: approximately up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.