Recurrence Rates of Type I Gastric Neuroendocrine Tumors Treated With Long-acting Somatostatin Analogs

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Gastric NET

Treatments: Drug: Octreotide

Study type: Observational

Funder types: Other

Identifiers

NCT03812939

ZS-1788

Details and patient eligibility

About

This study evaluates the efficacy of Long-acting Somastostatin analogs as treatment for type I gastric neuroendocrine tumors.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic diagnosis of gastric neuroendocrine tumor.
• Clinical diagnosis of Type I gastric NET: neuroendocrine tumor arising from atrophic body gastritis (ABG diagnosis should be based on hypergastrinemia and histological confirmation of gastric body atrophy on multiple biopsies performed in gastric antrum and body).
• Previous esophagogastroduodenoscopy: all visible NETs resected with R0 margin, confirmed no visible gastric NETs left, multiple biopsies taken to evaluate gastric atrophy and ECL status.
• No tumor metastases confirmed by endoscopic ultrasonography, CT scan or somatostatin receptor scintigraphy.
• SSA therapy is recommended by physician for disease management, and has not yet begun.
• Written informed consent obtained prior to treatment to be consistent with local regulatory requirements.

Exclusion criteria

• Pathological grading as G3 NET (Ki-67>20%).
• Patients with a known hypersensitivity to somatostatin analogs.
• Known gallbladder or bile duct disease, acute or chronic pancreatitis.
• Known medical condition related with prolonged QT interval.
• Pregnant or lactating women.
• Patients with serious complicated infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy.
• Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for > 5 years will be allowed to enter the trial.
• Patients with a history of non-compliance to medical regimens.