Neuroendocrine Neoplasms (Tumours)Phase 2NCT07279532
Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System
A Phase 2 study testing surufatinib in people with Neuroendocrine Neoplasms (Tumours), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
The following issues warrant in-depth investigation: further refinement of staging by primary tumor site, the increasing prognostic weight of T classification, risk assessment for lymph node metastasis and postoperative recurrence/distant metastasis, and whether NET G3 with poor prognosis requires more aggressive… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuroendocrine Neoplasms (Tumours)
- What is being tested?
- surufatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent and voluntarily participate in the study.
- Aged 18-80 years, male or female.
- Confirmed as Stage III NET G1/G2 or any-stage NET G3 after surgical treatment.
- Other postoperative NET patients deemed by the investigator to have high-risk factors.
- Adequate organ function meeting the following criteria (no use of any blood components, cell growth factors, or corrective drugs within 14 days prior to the first dose of the study drug): (i) Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; (ii) Platelets ≥100×10⁹/L; (iii) Hemoglobin ≥8 g/dL; (iv) Total Bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (or ≤5 × ULN if liver metastases are present); (v) Serum Creatinine ≤1.5 × ULN or Creatinine Clearance >60 mL/min (Cockcroft-Gault formula).
- Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first study drug dose and use effective contraception during the study and for at least 3 months after the last dose. Male subjects with female partners of childbearing potential must use effective contraception during the study and for 3 months after the last dose.
Who cannot join
- Major surgery, open biopsy, or significant trauma within 28 days prior to the first dose.
- History of severe or poorly controlled interstitial lung disease.
- Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite antihypertensive medication.
- Poorly controlled cardiovascular diseases, including but not limited to:
- (i)NYHA Class II or higher heart failure; (ii) Unstable angina; (iii) Myocardial infarction within the past year; (iv) Clinically significant supraventricular or ventricular arrhythmias poorly controlled with or without intervention.
- Significant bleeding tendency or clinically significant bleeding within 3 months prior to the first dose (e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis).
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- Arterial/venous thrombotic events within 6 months prior to the first dose (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis, pulmonary embolism). Superficial vein thrombosis may be enrolled if deemed eligible by the investigator.
- Concurrent active malignancy requiring treatment, except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix.
- Pregnancy or lactation.
- Any other condition deemed by the investigator to potentially lead to study discontinuation (e.g., severe comorbid illnesses, abnormal laboratory values, psychosocial issues).
About this study
The following issues warrant in-depth investigation: further refinement of staging by primary tumor site, the increasing prognostic weight of T classification, risk assessment for lymph node metastasis and postoperative recurrence/distant metastasis, and whether NET G3 with poor prognosis requires more aggressive postoperative intervention. This study plans to enroll patients classified as Stage III according to the AJCC 9th Edition staging system, including NET G1/G2 and all G3 patients, for a clinical trial on postoperative adjuvant therapy.
- Conditions
- Neuroendocrine Neoplasms (Tumours)
- Being tested
- surufatinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinibDrug
Surufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Surufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy. Receives: Drug: surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Free Survival（RFS）
Refers to the time from when a patient achieves complete response after anticancer therapy or surgery until the occurrence of disease recurrence or death from any cause.
Measured: 4 years
Secondary outcomes (2)
Overall Survival （OS）
Refers to the time from the start of randomization (or the start of treatment in a single-arm trial) until death due to any cause.
Measured: 4 years
Adverse Event (AE)
In a drug clinical trial, it refers to all adverse medical events that occur in subjects after receiving the investigational medicinal product, which can manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Neoplasms (Tumours)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279532
- Sponsor's protocol ID
- 2025-1173
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Adjuvant Surufatinib Therapy for Postoperative High-risk Neuroendocrine Tumors Based on the Ninth Edition of the AJCC Staging System
- ClinicalTrials.gov ID
- NCT07279532
- Acronym / sponsor ID
- 2025-1173
- Conditions
- Neuroendocrine Neoplasms (Tumours)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Dec 2025 (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.
The following issues warrant in-depth investigation: further refinement of staging by primary tumor site, the increasing prognostic weight of T classification, risk assessment for lymph node metastasis and postoperative recurrence/distant metastasis, and whether NET G3 with poor prognosis requires more aggressive postoperative intervention. This study plans to enroll patients classified as Stage III according to the AJCC 9th Edition staging system, including NET G1/G2 and all G3 patients, for a clinical trial on postoperative adjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: surufatinibSurufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent and voluntarily participate in the study.
- Aged 18-80 years, male or female.
- Confirmed as Stage III NET G1/G2 or any-stage NET G3 after surgical treatment.
- Other postoperative NET patients deemed by the investigator to have high-risk factors.
- Adequate organ function meeting the following criteria (no use of any blood components, cell growth factors, or corrective drugs within 14 days prior to the first dose of the study drug): (i) Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L; (ii) Platelets ≥100×10⁹/L; (iii) Hemoglobin ≥8 g/dL; (iv) Total Bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (or ≤5 × ULN if liver metastases are present); (v) Serum Creatinine ≤1.5 × ULN or Creatinine Clearance >60 mL/min (Cockcroft-Gault formula).
Key exclusion criteria (10 listed)
- Major surgery, open biopsy, or significant trauma within 28 days prior to the first dose.
- History of severe or poorly controlled interstitial lung disease.
- Poorly controlled hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg) despite antihypertensive medication.
- Poorly controlled cardiovascular diseases, including but not limited to:
- (i)NYHA Class II or higher heart failure; (ii) Unstable angina; (iii) Myocardial infarction within the past year; (iv) Clinically significant supraventricular or ventricular arrhythmias poorly controlled with or without intervention.
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 |
|---|---|---|
| surufatinibSurufatinib 200mg, administered orally once daily (QD), for 6 months as postoperative adjuvant therapy. | Drug | Experimental Group |
Primary outcome
Recurrence Free Survival（RFS）
Time frame: 4 years
Refers to the time from when a patient achieves complete response after anticancer therapy or surgery until the occurrence of disease recurrence or death from any cause.
2 secondary outcomes
Overall Survival （OS）
Time frame: 4 years
Adverse Event (AE)
Time frame: 4 years
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 12 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing surufatinib in people with Neuroendocrine Neoplasms (Tumours), run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 6 inclusion and 10 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 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Free Survival（RFS） (time frame: 4 years). 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 12 Dec 2025.