Real-world Study on Adjuvant Octreotide Therapy in pNETs

Naval Military Medical University

Status: Completed

Conditions: Pancreatic Neuroendocrine Tumor G2

Treatments: Drug: Octreotide LAR

Study type: Interventional

Funder types: Other

Identifiers

NCT06080204

ChanghaiH-PP12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 411 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

411 participants in 2 patient groups

Octreotide group

Experimental group

Description:

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.

Treatment:

Drug: Octreotide LAR

Control group

No Intervention group

Description:

No adjuvant therapy after surgery.