Current partner codePEPTIDESDE
NCT07534371·Not applicable·OBSERVATIONAL

Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study

Status

Active, not recruiting

Phase

Not applicable

Enrollment

500

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

surufatinib

Oral tyrosine kinase inhibitor, 250mg or 300mg daily until disease progression or unacceptable toxicity.

DRUG

Somatostatin Analogs

Long-acting release formulation of octreotide or lanreotide, administered via intramuscular or deep subcutaneous injection every 4 weeks until disease progression.

Timeline

From registration to results.

  1. First posted

    Apr 16, 2026

  2. Study start

    Mar 6, 2026

  3. Primary completion

    Jul 2026

  4. Study completion

    Jul 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 16, 2026

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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). Exclusion Criteria: * 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).

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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