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

NCT07057622 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2025-07-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • HTA Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-12
Primary Completion
2026-11-24
Completion
2027-02-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057622 on ClinicalTrials.gov