Neuroendocrine TumorsNCT07534371
Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study
An observational study of Neuroendocrine Tumors, run by West China Hospital at 1 site in China.
Trial summary
This is a multicenter retrospective cohort study designed to compare the efficacy differences between two treatment sequence-"first-line surufatinib and second-line somatostatin analogs (SSA)" versus "first-line SSA and second-line surufatinib"-in patients with advanced neuroendocrine tumors (NETs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- surufatinib and Somatostatin Analogs
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2026to Jul 2026
- 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: Patients with histopathologically confirmed advanced G1/G2, SSTR2-positive NETs who received either first-line surufatinib followed by second-line SSA (Cohort A) or first-line SSA followed by second-line surufatinib (Cohort B). Patients with incomplete data for PFS assessment or who received combined systemic therapy during first-line or second-line treatment are excluded. Approximately 500 patients will be enrolled from six tertiary hospitals in China.
Who may be able to join
- Histopathologically confirmed locally advanced unresectable, metastatic, or postoperative recurrent neuroendocrine tumors (NETs), any primary site.
- Grade G1 or G2 based on Ki-67 index and/or mitotic count.
- Somatostatin receptor 2 (SSTR2) positive confirmed by immunohistochemistry (IHC) or somatostatin receptor imaging (e.g., 68Ga-PET/CT).
- Received one of the following two sequential treatment patterns:
- Cohort A (Surufatinib → SSA): First-line surufatinib monotherapy followed by second-line long-acting somatostatin analog (SSA; lanreotide or octreotide long-acting release formulation) after disease progression.
- Cohort B (SSA → Surufatinib): First-line long-acting SSA monotherapy followed by second-line surufatinib after disease progression.
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- Each line of treatment duration at least 1 cycle (surufatinib ≥4 weeks; SSA ≥1 injection).
- Complete baseline clinical data, treatment start/end dates, and serial imaging evaluation reports available to determine progression-free survival for each line.
- Age ≥18 years at first-line treatment initiation.
- Permitted concomitant treatments during study drug administration (not considered as exclusion criteria):
- Best supportive care (e.g., antidiarrheals, analgesics, hepatoprotective agents, symptomatic treatment for hormone secretion).
- Local palliative interventions for focal lesions (e.g., transarterial embolization/chemoembolization, ablation for liver metastases) or cytoreductive surgery, provided they do not interrupt systemic study treatment or violate protocol.
- For functional NETs, short-acting somatostatin analogs as rescue therapy for symptom control (frequency and dose to be recorded).
Who cannot join
- Received any combined systemic therapy (e.g., chemotherapy, other targeted therapy, immunotherapy) in addition to surufatinib or SSA during first-line or second-line treatment.
- Missing key baseline data (e.g., pathological grade, primary tumor site) or incomplete treatment/follow-up imaging data precluding accurate assessment of progression-free survival.
- Presence of active, uncontrolled serious infection or another active malignancy at the start of first-line treatment that may interfere with assessment of neuroendocrine tumor progression or patient survival prognosis (except cured skin basal cell carcinoma or carcinoma in situ).
Trial locations and contacts
1 site in 1 country.
About this study
This is a multicenter retrospective cohort study designed to compare the efficacy differences between two treatment sequence-"first-line surufatinib and second-line somatostatin analogs (SSA)" versus "first-line SSA and second-line surufatinib"-in patients with advanced neuroendocrine tumors (NETs). The primary endpoint is progression-free survival (PFS) from the initiation of first-line therapy to progression on second-line treatment. Secondary endpoints include PFS for each individual line of therapy, safety profiles, and exploration of influencing factors. This study aims to identify the optimal treatment sequence and to provide real-world evidence for optimizing individualized treatment strategies for patients with advanced NETs, thereby informing clinical decision-making in routine practice.
- Conditions
- Neuroendocrine Tumors
- Being tested
- surufatinib, Somatostatin Analogs
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surufatinibDrug
Oral tyrosine kinase inhibitor, 250mg or 300mg daily until disease progression or unacceptable toxicity.
Somatostatin AnalogsDrug
Long-acting release formulation of octreotide or lanreotide, administered via intramuscular or deep subcutaneous injection every 4 weeks until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (Surufatinib→SSA) | Not described Receives: Drug: surufatinib; Drug: Somatostatin Analogs | |
| Cohort B (SSA→Surufatinib) | Not described Receives: Drug: surufatinib; Drug: Somatostatin Analogs |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: From start of first-line treatment (either surufatinib or SSA) to disease progression on second-line treatment, assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start6 Mar 2026
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, National Cancer Center, China, The First Affiliated Hospital of Zhengzhou University, Beijing 302 Hospital, China-Japan Friendship Hospital
- Responsible party
- Principal investigator, Dan Cao, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534371
- Sponsor's protocol ID
- 2026(562)
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07534371
- Acronym / sponsor ID
- 2026(562)
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University, National Cancer Center, China, The First Affiliated Hospital of Zhengzhou University, Beijing 302 Hospital, China-Japan Friendship Hospital
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 Apr 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.
This is a multicenter retrospective cohort study designed to compare the efficacy differences between two treatment sequence-"first-line surufatinib and second-line somatostatin analogs (SSA)" versus "first-line SSA and second-line surufatinib"-in patients with advanced neuroendocrine tumors (NETs). The primary endpoint is progression-free survival (PFS) from the initiation of first-line therapy to progression on second-line treatment. Secondary endpoints include PFS for each individual line of therapy, safety profiles, and exploration of influencing factors. This study aims to identify the optimal treatment sequence and to provide real-world evidence for optimizing individualized treatment strategies for patients with advanced NETs, thereby informing clinical decision-making in routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (Surufatinib→SSA) | – | Drug: surufatinib, Drug: Somatostatin Analogs |
| Cohort B (SSA→Surufatinib) | – | Drug: surufatinib, Drug: Somatostatin Analogs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histopathologically confirmed advanced G1/G2, SSTR2-positive NETs who received either first-line surufatinib followed by second-line SSA (Cohort A) or first-line SSA followed by second-line surufatinib (Cohort B). Patients with incomplete data for PFS assessment or who received combined systemic therapy during first-line or second-line treatment are excluded. Approximately 500 patients will be enrolled from six tertiary hospitals in China.
Key inclusion criteria (13 listed)
- Histopathologically confirmed locally advanced unresectable, metastatic, or postoperative recurrent neuroendocrine tumors (NETs), any primary site.
- Grade G1 or G2 based on Ki-67 index and/or mitotic count.
- Somatostatin receptor 2 (SSTR2) positive confirmed by immunohistochemistry (IHC) or somatostatin receptor imaging (e.g., 68Ga-PET/CT).
- Received one of the following two sequential treatment patterns:
- Cohort A (Surufatinib → SSA): First-line surufatinib monotherapy followed by second-line long-acting somatostatin analog (SSA; lanreotide or octreotide long-acting release formulation) after disease progression.
Key exclusion criteria (3 listed)
- Received any combined systemic therapy (e.g., chemotherapy, other targeted therapy, immunotherapy) in addition to surufatinib or SSA during first-line or second-line treatment.
- Missing key baseline data (e.g., pathological grade, primary tumor site) or incomplete treatment/follow-up imaging data precluding accurate assessment of progression-free survival.
- Presence of active, uncontrolled serious infection or another active malignancy at the start of first-line treatment that may interfere with assessment of neuroendocrine tumor progression or patient survival prognosis (except cured skin basal cell carcinoma or carcinoma in situ).
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 |
|---|---|---|
| surufatinibOral tyrosine kinase inhibitor, 250mg or 300mg daily until disease progression or unacceptable toxicity. | Drug | Cohort A (Surufatinib→SSA), Cohort B (SSA→Surufatinib) |
| Somatostatin AnalogsLong-acting release formulation of octreotide or lanreotide, administered via intramuscular or deep subcutaneous injection every 4 weeks until disease progression. | Drug | Cohort A (Surufatinib→SSA), Cohort B (SSA→Surufatinib) |
Primary outcome
PFS
Time frame: From start of first-line treatment (either surufatinib or SSA) to disease progression on second-line treatment, assessed up to 60 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 16 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Tumors, run by West China Hospital 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 13 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 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?
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?
PFS (time frame: From start of first-line treatment (either surufatinib or SSA) to disease progression on second-line treatment, assessed up to 60 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 16 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.