A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

196

Participants

Timeline

Start Date

August 31, 2022

Primary Completion Date

June 26, 2024

Study Completion Date

December 31, 2028

Conditions
Neuroendocrine Tumors
Interventions
DRUG

Lutetium[177Lu] Oxodotreotide Injection

Four 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.

DRUG

Octreotide LAR

60 mg Octreotide LAR treatment was given to the participants every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.

Trial Locations (23)

100853

Chinese PLA General Hospital, Beijing

130021

The first hospital of Jilin University, Changchun

200032

Fudan University Shanghai Cancer Center, Shanghai

Zhongshan Hospital, Fudan University, Shanghai

210006

Nanjing First Hospital, Nanjing

250012

Qilu Hospital of Shandong University, Jinan

300060

Tianjin Medical University Cancer Institute & Hospital, Tianjin

310003

The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

350005

The First Afilliated Hospital of Fujian Medical University, Fuzhou

361003

The First Affiliated Hospital of Xiamen University, Xiamen

430022

Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan

430030

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan

450003

Henan Provincial People's Hospital, Zhengzhou

450052

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

510080

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

510630

The First Affiliated Hospital of Jinan University, Guangzhou

610041

West China Hospital of Sichuan University, Chengdu

621099

Mianyang Central Hospital, Mianyang

646000

Affiliated Hospital of Southwest Medical University, Luzhou

710032

The First Affiliated Hospital of AFMU, Xi'an

710061

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

030012

The First Affiliated Hospital of Shanxi Medical University, Taiyuan

All Listed Sponsors
lead

Sinotau Pharmaceutical Group

INDUSTRY