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

NCT07534371 | Active Not Recruiting

• 1 other identifier: 2026(562)
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• PFS

  From start of first-line treatment (either surufatinib or SSA) to disease progression on second-line treatment, assessed up to 60 months.

Study Arms (2)

Cohort A (Surufatinib→SSA)

Drug: surufatinib; Drug: Somatostatin Analogs

Cohort B (SSA→Surufatinib)

Drug: surufatinib; Drug: Somatostatin Analogs

Interventions

surufatinib DRUG

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

Cohort A (Surufatinib→SSA); Cohort B (SSA→Surufatinib)

Somatostatin Analogs DRUG

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

Cohort A (Surufatinib→SSA); Cohort B (SSA→Surufatinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• West China Hospital: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• National Cancer Center/National Cancer Clinical Medical Research Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Beijing 302 Hospital: collaborator
• China-Japan Friendship Hospital: collaborator

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)