Advanced Gastroenteropancreatic Neuroendocrine TumorPhase 3NCT05884255
An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
A Phase 3 study testing Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide and long-acting Octreotide in people with Advanced Gastroenteropancreatic Neuroendocrine Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastroenteropancreatic Neuroendocrine Tumor
- What is being tested?
- Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide and long-acting Octreotide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesChina
- Study dates
- 6 Jul 2023to Oct 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide a written informed consent;
- 18~75 years old,male or female;
- ECOG performance status 0 or 1;
- Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology.
Who cannot join
- Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks;
- There are clinical symptoms or diseases of the heart that are not well controlled;
- Diabetes (fasting blood glucose > 2 × ULN) that cannot be well controlled after optimal medical support treatment;
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 201321
Xianjun Yu, +86-021-64175590, yuxianjun@fudanpci.org
Xianjun Yu
- Recruiting
Tianjin University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Jihui Hao, 022-23353454, herenrh@163.com
Jihui Hao
About this study
Official title: Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
- Being tested
- Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide, long-acting Octreotide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium (177Lu) Oxodotreotide Injection；long-acting OctreotideDrug
Lutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide.
long-acting OctreotideDrug
High-dose long-acting Octreotide.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A | Experimental | Not described Receives: Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide |
| Treatment group B | Active comparator | Not described Receives: Drug: long-acting Octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by BICR
Measured: Up to 1 year follow-up
Secondary outcomes (5)
Overall Survival (OS)
Measured: Up to 5 years follow-up
Objective Response Rate (ORR)
Measured: up to 1 year follow-up
Duration of Overall Response (DoR)
Measured: Up to 1 year follow-up
Disease Control Rate (DCR)
Measured: Up to 1 year follow-up
Incidence and severity of adverse event (AE) and serious adverse event (SAE)
Measured: Up to 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start6 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastroenteropancreatic Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884255
- Sponsor's protocol ID
- HRFS-Q-2011-301
- Status last verified
- May 2026
- First submitted
- 22 May 2023
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open, Positive Control Phase III Clinical Trial of Lutetium (177Lu) Oxodotreotide Injection Combined With Standard-dose Long-acting Octreotide Versus High-dose Long-acting Octreotide in the Treatment of Somatostatin Receptor-positive Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.
- ClinicalTrials.gov ID
- NCT05884255
- Acronym / sponsor ID
- HRFS-Q-2011-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group A | Experimental | Drug: Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide |
| Treatment group B | Active comparator | Drug: long-acting Octreotide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to provide a written informed consent;
- 18~75 years old,male or female;
- ECOG performance status 0 or 1;
- Unresectable locally advanced or metastatic gastrointestinal neuroendocrine tumors (GEP-NETs) of low and medium grade (G1 or G2) confirmed by histopathology.
Key exclusion criteria (4 listed)
- Central nervous system metastasis is known. Patients who have previously received treatment ( radiotherapy or surgery ) for brain metastases and have no clinical symptoms can be enrolled if the pre-randomized pre-imaging is confirmed to be stable for at least 24 weeks;
- There are clinical symptoms or diseases of the heart that are not well controlled;
- Diabetes (fasting blood glucose > 2 × ULN) that cannot be well controlled after optimal medical support treatment;
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction or indwelling catheter for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutetium (177Lu) Oxodotreotide Injection；long-acting OctreotideLutetium (177Lu) Oxodotreotide Injection combined with standard-dose long-acting Octreotide. | Drug | Treatment group A |
| long-acting OctreotideHigh-dose long-acting Octreotide. | Drug | Treatment group B |
Primary outcome
Progression-free survival (PFS) assessed by BICR
Time frame: Up to 1 year follow-up
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years follow-up
Objective Response Rate (ORR)
Time frame: up to 1 year follow-up
Duration of Overall Response (DoR)
Time frame: Up to 1 year follow-up
Disease Control Rate (DCR)
Time frame: Up to 1 year follow-up
Incidence and severity of adverse event (AE) and serious adverse event (SAE)
Time frame: Up to 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Gastroenteropancreatic Neuroendocrine Tumor
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
RecruitingPhase 1/2
Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
Neuroendocrine Tumors Unresectable, Neuroendocrine Tumor Metastatic
Not yet recruitingPhase 1
211At-MABG in Adults With Advanced Neuroendocrine Cancers
Pheochromocytoma, Paraganglioma
Active, not recruitingPhase 3
Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor
Active, not recruitingPhase 2
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lutetium (177Lu) Oxodotreotide Injection；long-acting Octreotide and long-acting Octreotide in people with Advanced Gastroenteropancreatic Neuroendocrine Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueying Zheng (+86-0518-82342973, xueying.zheng.xz17@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by BICR (time frame: Up to 1 year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.