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| Name | Class |
|---|---|
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| National Cancer Center, China | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A (Surufatinib→SSA) |
| ||
| Cohort B (SSA→Surufatinib) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surufatinib | Drug | Oral tyrosine kinase inhibitor, 250mg or 300mg daily until disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | From start of first-line treatment (either surufatinib or SSA) to disease progression on second-line treatment, assessed up to 60 months. |
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Inclusion Criteria:
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.
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).
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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| Beijing 302 Hospital |
| OTHER |
| China-Japan Friendship Hospital | OTHER |
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| Somatostatin Analogs | Drug | Long-acting release formulation of octreotide or lanreotide, administered via intramuscular or deep subcutaneous injection every 4 weeks until disease progression. |
|
| D009380 | Neoplasms, Nerve Tissue |