Neuroendocrine Tumors
Conditions
Brief 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). 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.
Interventions
DRUGsurufatinib
Oral tyrosine kinase inhibitor, 250mg or 300mg daily until disease progression or unacceptable toxicity.
DRUGSomatostatin Analogs
Long-acting release formulation of octreotide or lanreotide, administered via intramuscular or deep subcutaneous injection every 4 weeks until disease progression.
Sponsors
West China Hospital
First Affiliated Hospital Xi'an Jiaotong University
National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
The First Affiliated Hospital of Zhengzhou University
Beijing 302 Hospital
China-Japan Friendship Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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).
Design outcomes
Primary
| Measure | 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. |
Countries
China
Outcome results
None listed