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NOT YET RECRUITING
NCT05894486
PHASE2

Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

Sponsor: Peking University

View on ClinicalTrials.gov

Summary

his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium\[177Lu\] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.

Official title: Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Inoperable Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-06-05

Completion Date

2026-06-05

Last Updated

2023-06-08

Healthy Volunteers

No

Interventions

DRUG

Lutetium[177Lu] Oxodotreotide Injection

Lutetium\[177Lu\] Oxodotreotide InjectionFour administrations of 7.4 GBq (200 mCi) Lutetium\[177Lu\] Oxodotreotide Injection administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China