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CompletedNCT06080204Updated Oct 18, 2023

Real-world Study on Adjuvant Octreotide Therapy in pNETs

An interventional study of Octreotide LAR in Pancreatic Neuroendocrine Tumor G2, sponsored by Changhai Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 15 years 6 months after the study started (first participant enrolled Mar 2008, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
411
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

Adjuvant therapy in pancreatic neuroendocrine tumors (pNETs) after radical resection lacks evidence-based data and is controversial. Real-world data were clustered to validate whether the long-acting octreotide is a potential candidate for adjuvant therapy in high recurrence risk G2 pNET patients.

Read the detailed description

Adjuvant therapy for pNETs was proposed as an unmet clinical need by the European Neuroendocrine Tumor Society Group in 2016.1The Clinical Practice Guidelines for pNETs in China recommended initiation of clinical trials to investigate the role of adjuvant therapy for patients with a high-risk of recurrence. To address this unmet clinical need, the investigators initiated this real-world study. The aim of the current study was to assess the impact of octreotide LAR as an adjuvant therapy in reducing recurrence and prolonging survival in Chinese non-metastatic pNETs patients at risk for recurrence.

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Conditions studied

  • Pancreatic Neuroendocrine Tumor G2
03

In context

Neuroendocrine Tumors

676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.

This study's enrollment of 411 is above the median of 42 across 464 interventional studies indexed under Neuroendocrine Tumors.

Browse Neuroendocrine Tumors studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • pNETs lesions pathologically classified as WHO grade 2
  • Complete surgical resection (R0 or R1 was achieved)
  • Adjuvant treatment was performed within 12 weeks after surgery

Exclusion criteria

Exclusion Criteria:

  • Stage IV
  • Other oncological history
  • Previous antineoplastic systemic therapy
  • Lack of information/details on recurrence or death.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
411 participants (actual)

Study arms

  • Experimental
    Octreotide group

    Patients in the octreotide group received octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months, with the start of clinical intervention following surgery.

    Drug: Octreotide LAR

  • No intervention
    Control group

    No adjuvant therapy after surgery.

Interventions

  • DrugOctreotide LAR

    Octreotide LAR (Sandostatin® LAR, Novartis Pharmaceuticals Corporation) treatment by deep intramuscular injection at a dose of 30 mg every 28 days for 6-12 months。

    Also known as: Sandostatin

06

What researchers measure

Primary outcomes

  1. Disease-free survival time

    Disease-free survival time

    Time frame: From the date of surgery to the date of distant metastasis or recurrence or death due to any cause, whichever came first, assessed up to 120 months

Secondary outcomes

  1. Overall survival time

    Overall survival time

    Time frame: From the date of surgery to the date of death due to any cause, whichever came first, assessed up to 120 months

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06080204
Lead sponsor
Changhai Hospital
Responsible party
Guo ShiWei (Clinical Professor, Changhai Hospital) — Principal investigator
First posted
Oct 12, 2023
Start date
Mar 2008
Primary completion
Apr 2020
Completion
Apr 2020
Last update
Oct 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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