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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

Neuroendocrine Tumors Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were assigned to treatment with Lutetium[177Lu] Oxodotreotide Injection. Objective tumor assessment in both groups was performed every 12+/-1 weeks from the first treatment date according to RECIST 1.1 Criteria until progression. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05894486
Study type Interventional
Source Peking University
Contact Ming Lu, professor
Phone 86-10-88196561
Email qiminglu_mail@126.com
Status Not yet recruiting
Phase Phase 2
Start date June 5, 2023
Completion date June 5, 2026
View Details
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