NCT07057622

A Phase III Clinical Study to Compare the Safety and Efficacy of 177Lu-DOTATATE Injection and Long-acting Oxytrexine in Adult Patients With NETs

Compare the Safety and Efficacy of 177Lu-DOTATATE and Octreotide LAR in Unresectable or Metastatic, Progressive, Well-differentiated(G1 and G2) and SSTR-positive Adult GEP-NEN

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: HTA Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate the sstr antagonists, 68Ga-DOTATATE and 177Lu-DOTATATE,as a pair of diagnostic/therapeuticradiopharmaceuticals(theranostics)in patients with NETS

Conditions

• NETS Ga68 Lu177

Interventions

Type	Name	Description
DRUG	177Lu-DOTATATE injection	The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the test group are treated with 177Lu-DOTATATE injection, 7.4GBq±0.74GBq (200mCi±20mCi)/cycle, once every 8 to 12 weeks, 4 times in total.
DRUG	Octreotide LAR (Long-acting release)	The eligible subjects who participate in 177Lu study are randomly assigned 1:1 to either the test group or the control group to receive treatment. Subjects in the treatment group are treated with 60mg of long-acting octreotide once every 4 weeks±3 days.

Timeline

• Start date: 2023-12-12
• Primary completion: 2026-11-24
• Completion: 2027-02-24
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: China