Advanced Neuroendocrine NeoplasmPhase 2/3NCT06398444
A Clinical Study of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Neuroendocrine Neoplasms
A Phase 2/3 study testing Lutetium[177Lu] Oxodotreotide Injection in people with Advanced Neuroendocrine Neoplasm, run by Sinotau Pharmaceutical Group at 1 site in China.
Trial summary
This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium [177Lu] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Advanced Neuroendocrine Neoplasm
- What is being tested?
- Lutetium[177Lu] Oxodotreotide Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2024to 1 Jun 2029
- Phase
- Phase 2/3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).
- Age ≥12 years; subjects aged 12-17 years must have a body weight ≥40kg. Age eligibility must be met at the time of signing the ICF.
- Histologically confirmed, unresectable locally advanced or metastatic neuroendocrine neoplasms (NENs) [excluding well-differentiated (G1 and G2) gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) and neuroendocrine carcinomas (NECs)]. The target population mainly includes:
- (1)Grade 3 (G3) GEP-NET with Ki-67 index ≤ 55% (2)Other non-gastroenteropancreatic originated NEN, including pulmonary/thymic NEN, primary NEN of other sites, and NEN of unknown primary origin (3)Pheochromocytoma and paraganglioma (PPGL) Note: Histopathological specimens collected within 3 years prior to the first study drug administration are acceptable, provided that investigators confirm they can represent the pathological status at enrollment; otherwise, fresh specimens shall be collected.
- 4. Patients who have failed prior optimal available treatment, are intolerant to optimal available treatment, or have no access to optimal available treatment, with no restriction on the number of prior treatment lines.
- Note: Optimal available treatment is determined by investigators based on individual subject conditions, including chemotherapy, targeted therapy, biologic therapy, etc.
Show all 14Show fewer
- 5.Have documented disease progression within 1 year prior to the first study drug administration, and have not received any other systemic anti-tumor therapy after disease progression.
- 6.Have at least one measurable lesion at baseline per RECIST 1.1 criteria. 7. All baseline target lesions (per RECIST 1.1) must be confirmed as somatostatin receptor-positive via ⁶⁸Ga-Dotatate PET/CT.
- Notes:
- ⁶⁸Ga-Dotatate PET/CT images obtained within 24 weeks before the first drug administration are acceptable if investigators verify they can reflect the somatostatin receptor status at enrollment;
- Somatostatin receptor positivity is defined as lesion uptake higher than normal liver uptake;
- Subjects with any target lesion confirmed somatostatin receptor-negative by ⁶⁸Ga-Dotatate PET/CT shall be excluded.
- 8. Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at baseline.
- 9. Subjects of childbearing potential must voluntarily use effective contraceptive methods throughout the treatment period and for 4 months (male) or 7 months (female) after the last dose of investigational product, such as condoms, oral/injectable contraceptives, intrauterine devices, etc.
Who cannot join
- Serum creatinine > 150 μmol/L (1.7 mg/dL) or creatinine clearance rate < 50 mL/min (calculated by Cockcroft-Gault formula).
- Hemoglobin < 100 g/L, white blood cell count < 2.0×10⁹/L, or platelet count < 100×10⁹/L.
- Total serum bilirubin > 3 times the upper limit of normal (ULN).
- Serum albumin < 30 g/L.
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5×ULN.
- International Normalized Ratio (INR) > 1.5 or activated partial thromboplastin time (APTT) > 1.5×ULN.
Show all 26Show fewer
- Positive human immunodeficiency virus (HIV) antibody.
- Positive hepatitis B surface antigen (HBsAg) combined with positive HBV-DNA (≥1×10⁴ copies/mL or confirmed positive per local study center criteria); or positive hepatitis C virus (HCV) antibody combined with positive HCV-RNA (≥1×10³ copies/mL).
- Pregnant or breastfeeding females.
- Prior history of peptide receptor radionuclide therapy (PRRT).
- Subjects receiving short-acting octreotide who cannot discontinue it within 24 hours before and after administration of Lutetium-177 Oxotreotide Injection; or subjects receiving octreotide acetate microspheres who cannot stop the treatment within 6 weeks prior to the first dose of Lutetium-177 Oxotreotide Injection.
- Note: Further evaluation is required for subjects receiving other somatostatin analog (SSA) treatments.
- Received systemic anti-tumor therapies including targeted therapy, immunotherapy, anti-tumor traditional Chinese medicine therapy or chemotherapy within 4 weeks before the first study drug administration.
- Enrolled in other clinical trials and received investigational drugs within 4 weeks prior to the first dose.
- Received local anti-tumor treatments such as surgery (excluding biopsy), radical radiotherapy, hepatic arterial chemoembolization, cryoablation or radiofrequency ablation for liver metastases within 4 weeks before the first dose.
- Received palliative radiotherapy for bone metastases within 2 weeks prior to the first dose.
- Toxicities from previous anti-tumor therapies have not recovered to Grade 1 or lower (alopecia excluded).
- Confirmed brain metastases (excluding those stabilized for at least 24 weeks before the first administration).
- Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) < 50%.
- Uncontrolled diabetes mellitus, including baseline fasting blood glucose > 2×ULN.
- Presence of active infections requiring intravenous antibacterial drugs or inpatient intervention.
- History of other confirmed malignant tumors (excluding those with complete treatment and expected no recurrence within 5 years).
- Known hypersensitivity to any ingredients or excipients of Lutetium-177 Oxotreotide Injection and octreotide acetate microspheres.
- Contraindications to contrast-enhanced CT and MRI contrast agents due to allergic reactions or renal insufficiency.
- Any uncontrolled diseases, mental disorders or surgical conditions that may affect study completion (including poor treatment compliance) or make subjects ineligible for the investigational product.
- Based on the patient's disease characteristics, the investigator judges that alternative treatments such as chemotherapy and targeted therapy are more suitable for the patient than the study treatment, meaning the investigational product is not the optimal clinical treatment option.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jie Chen, MD, +86-021-68070288, Chen0jie@hotmail.com
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms
This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium [177Lu] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) and Neuroendocrine Carcinoma（NEC）.
Read the detailed description
This study consists of two parts, the exploratory study (Part 1) and the pivotal study (Part 2).
In both parts, participants who signs Informed consent form (ICF) and is eligible for the study will be enrolled. Participants will receive 7.4GBq (200mCi) Lutetium [177Lu] Oxyoctreotide every 8 weeks. The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 1.1 until disease progression.
- Conditions
- Advanced Neuroendocrine Neoplasm
- Being tested
- Lutetium[177Lu] Oxodotreotide Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium[177Lu] Oxodotreotide InjectionDrug
Participants will receive 7.4GBq (200mCi) Lutetium[177Lu] Oxodotreotide Injection every 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lutetium[177Lu] Oxodotreotide Injection | Experimental | Not described Receives: Drug: Lutetium[177Lu] Oxodotreotide Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (AE) (Part1)
Measured: Until 6 months after the last dose
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
Measured: Until disease progression or death, up to 5 years
Secondary outcomes (18)
Overall Response Rate (ORR) (Part 1)
Measured: Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 1)
Measured: Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 1)
Measured: Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 1)
Measured: Until disease progression or death, up to 5 years
Time to Progression (TTP) (Part 1)
Measured: Until disease progression or death, up to 5 years
PFS rate at 12 months (Part 1)
Measured: At 12 months after the first dose
Overall Survival (OS) (Part 1)
Measured: Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1)
Measured: Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1)
Measured: Until disease progression or death, up to 5 years
ORR assessed by investigators (part 2)
Measured: Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 2)
Measured: Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 2)
Measured: Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 2)
Measured: Until disease progression or death, up to 5 years
Overall Survival (OS) (Part 2)
Measured: Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2)
Measured: Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life GI.NET21 Questionnaire (Part 2)
Measured: Until disease progression or death, up to 5 years
Incidence and severity of AE (Part2)
Measured: Until 6 months after the last dose
The proportion of subjects with a reduction of at least 50% from baseline in antihypertensive medication that was sustained for more than 6 months (evaluated only in subjects with hypertension)
Measured: Until disease progression or death, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start11 Jun 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Neuroendocrine NeoplasmStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398444
- Sponsor's protocol ID
- XT-XTR008-2-02
- Status last verified
- Jul 2026
- First submitted
- 1 May 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Lutetium[177Lu] Oxodotreotide Injection in Patients With Advanced Somatostatin Receptor Positive Neuroendocrine Neoplasms
- ClinicalTrials.gov ID
- NCT06398444
- Acronym / sponsor ID
- XT-XTR008-2-02
- Conditions
- Advanced Neuroendocrine Neoplasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 3 May 2024 (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.
This is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of Lutetium [177Lu] Oxyoctreotide Injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (SSTR) positive neuroendocrine neoplasms (NEN) other than grade G1/G2 gastroenteropancreatic neuroendocrine tumors (GEP-NET) and Neuroendocrine Carcinoma（NEC）.
Detailed description
This study consists of two parts, the exploratory study (Part 1) and the pivotal study (Part 2).
In both parts, participants who signs Informed consent form (ICF) and is eligible for the study will be enrolled. Participants will receive 7.4GBq (200mCi) Lutetium [177Lu] Oxyoctreotide every 8 weeks. The objective tumor response will be assessed every 12 weeks from the time of the first dose according to RECIST 1.1 until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutetium[177Lu] Oxodotreotide Injection | Experimental | Drug: Lutetium[177Lu] Oxodotreotide Injection |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects who have been fully informed of this study and have voluntarily signed the Informed Consent Form (ICF).
- Age ≥12 years; subjects aged 12-17 years must have a body weight ≥40kg. Age eligibility must be met at the time of signing the ICF.
- Histologically confirmed, unresectable locally advanced or metastatic neuroendocrine neoplasms (NENs) [excluding well-differentiated (G1 and G2) gastro-entero-pancreatic neuroendocrine tumors (GEP-NETs) and neuroendocrine carcinomas (NECs)]. The target population mainly includes:
- (1)Grade 3 (G3) GEP-NET with Ki-67 index ≤ 55% (2)Other non-gastroenteropancreatic originated NEN, including pulmonary/thymic NEN, primary NEN of other sites, and NEN of unknown primary origin (3)Pheochromocytoma and paraganglioma (PPGL) Note: Histopathological specimens collected within 3 years prior to the first study drug administration are acceptable, provided that investigators confirm they can represent the pathological status at enrollment; otherwise, fresh specimens shall be collected.
- 4. Patients who have failed prior optimal available treatment, are intolerant to optimal available treatment, or have no access to optimal available treatment, with no restriction on the number of prior treatment lines.
Key exclusion criteria (26 listed)
- Serum creatinine > 150 μmol/L (1.7 mg/dL) or creatinine clearance rate < 50 mL/min (calculated by Cockcroft-Gault formula).
- Hemoglobin < 100 g/L, white blood cell count < 2.0×10⁹/L, or platelet count < 100×10⁹/L.
- Total serum bilirubin > 3 times the upper limit of normal (ULN).
- Serum albumin < 30 g/L.
- Alanine transaminase (ALT) or aspartate transaminase (AST) > 2.5×ULN.
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 InjectionParticipants will receive 7.4GBq (200mCi) Lutetium[177Lu] Oxodotreotide Injection every 8 weeks. | Drug | Lutetium[177Lu] Oxodotreotide Injection |
Primary outcome
Incidence and severity of adverse events (AE) (Part1)
Time frame: Until 6 months after the last dose
Overall Response Rate (ORR) assessed by Independent Review Committee (IRC) (Part 2)
Time frame: Until disease progression or death, up to 5 years
18 secondary outcomes
Overall Response Rate (ORR) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 1)
Time frame: Until disease progression or death, up to 5 years
Time to Progression (TTP) (Part 1)
Time frame: Until disease progression or death, up to 5 years
PFS rate at 12 months (Part 1)
Time frame: At 12 months after the first dose
Overall Survival (OS) (Part 1)
Time frame: Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 1)
Time frame: Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life Questionnaire (Part 1)
Time frame: Until disease progression or death, up to 5 years
ORR assessed by investigators (part 2)
Time frame: Until disease progression or death, up to 5 years
Progression-free survival (PFS) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Disease Control Rate (DCR) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Duration of Overall Response (DoR) (Part 2)
Time frame: Until disease progression or death, up to 5 years
Overall Survival (OS) (Part 2)
Time frame: Until death of any cause, up to 5 years
Change From Baseline in the EORTC QLQ-C30 Questionnaire (Part 2)
Time frame: Until disease progression or death, up to 5 years
Change From Baseline in the EORTC Quality of Life GI.NET21 Questionnaire (Part 2)
Time frame: Until disease progression or death, up to 5 years
Incidence and severity of AE (Part2)
Time frame: Until 6 months after the last dose
The proportion of subjects with a reduction of at least 50% from baseline in antihypertensive medication that was sustained for more than 6 months (evaluated only in subjects with hypertension)
Time frame: Until disease progression or death, up to 5 years
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 17 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Neuroendocrine Neoplasm
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Lutetium[177Lu] Oxodotreotide Injection in people with Advanced Neuroendocrine Neoplasm, run by Sinotau Pharmaceutical Group at 1 site 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 14 inclusion and 26 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 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shan Zhang (+86-010-52805710, zhangshan@sinotau.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (AE) (Part1) (time frame: Until 6 months after the last dose). The study lists 2 primary outcomes in all. 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 17 Jul 2026.