Neuroendocrine TumorsPhase 3NCT05459844
A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With GEP-NETs
A Phase 3 study testing Lutetium[177Lu] Oxodotreotide Injection and Octreotide LAR in people with Neuroendocrine Tumors, run by Sinotau Pharmaceutical Group at 23 sites in China.
Trial summary
This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium[177Lu] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Lutetium[177Lu] Oxodotreotide Injection and Octreotide LAR
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 23 sitesChina
- Study dates
- 31 Aug 2022to Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign a written informed consent document.
- Aged 18 years or older.
- Histopathologically confirmed low and moderate grade (G1 or G2) unresectable locally advanced or metastatic GEP-NET (based on the fifth edition of the WHO classification and grading criteria for neuroendocrine tumors of the digestive system in 2019, to be centrally confirmed).
- Previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression.
- Presence of disease progression prior to randomization (time point of disease progression limited to 1 year prior to randomization and no other antitumor therapy received after progression).
- Presence of at least 1 measurable site of disease (based on RECIST 1.1).
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- All target lesions (based on RECIST 1.1) at baseline must be confirmed as somatostatin receptor positive by 68Ga-Dotatate PET/CT .
- ECOG score of 0 or 1.
- Subjects of childbearing potential voluntarily use an effective method of contraception, such as condoms, oral or injectable contraceptives, IUDs, etc., during treatment and within 4 months (men) or 7 months (women) of the last use of the trial drug.
Who cannot join
- Serum creatinine >150 μmol/L (1.7 mg/dL) or creatinine clearance <50 ml/min (Cockcroft Gault formula).
- Hemoglobin <80g/L, or white blood cell count <2.0×10^9/L, or platelets <75×10^9/L.
- Serum total bilirubin > 3 × upper limit of normal (ULN).
- Serum albumin <30g/L.
- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5×ULN.
- international normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 x ULN.
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- Positive human immunodeficiency virus (HIV) antibody.
- Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and positive for HBV DNA (≥1×10^4 copies/ml or judged positive by research center criteria), or positive for hepatitis C virus (HCV) antibodies.
- Pregnant or lactating females.
- Received peptide receptor radionuclide therapy(PRRT) prior to randomization.
- Received Octreotide LAR at a dose strength >30 mg/3-4 weeks (increasing dose or frequency) within 12 weeks prior to randomization.
- Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of Lutetium[177Lu] Oxodotreotide Injection, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 6 weeks before the administration of Lutetium[177Lu] Oxodotreotide Injection.
- Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization.
- Participated in other drug clinical trials within 4 weeks prior to randomization and received treatment with the corresponding trial drug.
- Received the following treatments within 12 weeks prior to randomization, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation.
- Received external beam radiation therapy for bone metastases within 2 weeks prior to randomization
- Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia)
- Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study.
- Uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (LVEF) <50%.
- uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
- Any clinically significant active infection.
- Known other malignancies (except for those without recurrence within 5 years after adequate treatment)
- Known hypersensitivity to Lutetium[177Lu] Oxodotreotide Injection or oxytetracycline acetate microsphere components and their excipients.
- Known to be unsuitable for enhanced CT or MRI contrast imaging due to allergic reaction or renal insufficiency.
- Any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug.
- Other treatment options (e.g., chemotherapy, targeted therapy) that, in the opinion of the investigator, are more appropriate for the patient than the treatment provided in the study based on the patient's disease characteristics, i.e., the investigational drug is not the best therapeutic agent for clinical practice.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
The first hospital of Jilin University
Changchun, Jilin, 130021
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
The First Afilliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Mianyang Central Hospital
Mianyang, Sichuan, 621099
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030012
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430030
The First Affiliated Hospital of AFMU
Xi'an, Shaanxi, 710032
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, Well Differentiated, Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours
This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium[177Lu] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
Read the detailed description
After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutetium[177Lu] Oxodotreotide Injection or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by primary site of tumor (pancreatic or non-pancreatic), NET pathological grading (G1 or G2) and by the length of time that a participant was on a constant dose of Octreotide (=< 6 versus > 6 months). Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: any participants with progressive disease ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Lutetium[177Lu] Oxodotreotide Injection, Octreotide LAR
- Keywords
- Neuroendocrine tumour, 177Lu-Dota0-Tyr3-octreotate
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetium[177Lu] Oxodotreotide InjectionDrug
Also called 177Lu-DOTA0-Tyr3-Octreotate
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.
Octreotide LARDrug
Also called SANDOSTATIN LAR, Octreotide
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.
| Study group | Role | What they receive |
|---|---|---|
| Lutetium[177Lu] Oxodotreotide Injection | Experimental | Treatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) Lutetium[177Lu] Oxodotreotide Injection: Four administrations of 7.4 GBq (200 mCi).
Concomitant amino acids were given with each administration for kidney protection.
Lutetium[177Lu] Oxodotreotide Injection was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.
In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed. Receives: Drug: Lutetium[177Lu] Oxodotreotide Injection |
| Octreotide LAR | Active comparator | 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died.
In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed. Receives: Drug: Octreotide LAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) assessed by BIRC
Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Blinded Independent Review Committee (BIRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Secondary outcomes (15)
Progression Free Survival (PFS) assessed by investigator
Progression Free Survival (PFS) was defined as the time from randomization to documented investigator-assessed disease progression, or death due to any cause. If a participant had no investigator-assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Objective Response Rate (ORR) assessed by investigator
Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) and assessed by investigator according to RECIST 1.1.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Objective Response Rate (ORR) assessed by BIRC
Objective Response Rate (ORR) was calculated as the proportion of patients with tumour size reduction (sum of partial responses (PR) and complete responses (CR)) assessed by BIRC according to RECIST 1.1.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Duration of Response (DoR) assessed by investigator
The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression and assessed by investigator according to RECIST 1.1.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Duration of Response (DoR) assessed by BIRC
The Duration of Response (DoR) was defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression assessed by BIRC according to RECIST v1.1.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Time to Tumour Progression (TTP) assessed by investigator
Time to Tumour Progression (TTP) was defined as the time from randomization to progression assessed by investigator. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Time to Tumour Progression (TTP) assessed by BIRC
Time to Tumour Progression (TTP) was defined as the time from randomization to progression assessed by BIRC. It included patients who dropped out due to toxicity, but omitted patients who died without measured progression (censored to last follow-up date or death date).
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Disease Control Rate (DCR) assessed by investigator
DCR is defined as the incidence of complete response, partial response and stable disease assessed by investigator according to RECIST v1.1.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Disease Control Rate (DCR) assessed by BIRC
DCR is defined as the incidence of complete response, partial response and stable disease assessed by BIRC according to RECIST v1.1.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
20-month Progression-Free Survival rate assessed by BIRC
20-month Progression-Free Survival rate was defined as the proportion of patients whose time from randomization to disease progression by BIRC according to RECIST v1.1 or death exceeds 20 months.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
20-month Progression-Free Survival rate assessed by investigator
20-month Progression-Free Survival rate was defined as the proportion of patients whose time from randomization to disease progression by investigator according to RECIST v1.1 or death exceeds 20 months.
Measured: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause or the date of last contact (censored observation) prior to the date of the data cut-off, and during the entire study period (i.e. the treatment period plus follow-up).
Measured: From date of randomization until date of death from any cause up to final safety cut-off date reached，assessed up to approximately 60 months
Change From Baseline in the EORTC QLQ-C30 Questionnaire
The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly transformed so each score ranged a 0-100, where higher scores indicate worse symptoms (e.g., more severe/worsened) and lower scores indicate less symptoms (e.g., less severe/improvement).
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.
Measured: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Number of Participants With Adverse Events
The distribution of adverse events was done via the analysis of frequencies for Adverse Event (AEs), Serious Adverse Event (SAEs) and Deaths, through the monitoring of relevant clinical and laboratory safety parameters.
Measured: From informed consent signature through study completion reached at final safety cutoff date，assessed up to approximately 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start31 Aug 2022
- Primary completion26 Jun 2024
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neuroendocrine TumorsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianming Xu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459844
- Sponsor's protocol ID
- XT-XTR008-3-01
- Status last verified
- Aug 2025
- First submitted
- 5 Jul 2022
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu F, Yang H, Zhang J, Li J, Qiao Y, Chen J, Song S. Relationship between absorbed dose and SUV derived from SPECT/CT imaging and dose-response in patients with neuroendocrine tumors treated with [(1)(7)(7)Lu]Lu-DOTA-TATE. EJNMMI Res. 2026 Feb 25;16(1):52. doi: 10.1186/s13550-026-01402-2.
PubMed 41739362Liu F, Li P, Xu J, Zhang J, Xu X, Chen Z, Qiao Y, Liang Y, Chen J, Song S. Radiation exposure and protection advice after [177Lu]Lu-DOTA-TATE therapy in China. EJNMMI Res. 2024 Nov 28;14(1):119. doi: 10.1186/s13550-024-01185-4.
PubMed 39607652
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Treatment With Lutetium[177Lu] Oxodotreotide Injection to Octreotide LAR in Patients With Inoperable, Progressive, Well Differentiated, Somatostatin Receptor Positive Gastroenteropancreatic Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT05459844
- Acronym / sponsor ID
- XT-XTR008-3-01
- Conditions
- Neuroendocrine Tumors
- Keywords
- Neuroendocrine tumour, 177Lu-Dota0-Tyr3-octreotate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jul 2022 (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 was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutetium[177Lu] Oxodotreotide Injection to high dose (60 mg) Octreotide LAR in patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
Detailed description
After the screening period, participants who signed the ICF and were eligible for the study in accordance with the entry criteria were randomly assigned to treatment either Lutetium[177Lu] Oxodotreotide Injection or Octreotide LAR. Participant randomization was performed according to a centralized permuted block randomization scheme with a balanced ratio (1:1) between the 2 treatment groups, stratified by primary site of tumor (pancreatic or non-pancreatic), NET pathological grading (G1 or G2) and by the length of time that a participant was on a constant dose of Octreotide (=< 6 versus > 6 months). Objective tumor assessment in both groups was performed every 12+/-1 weeks from the randomization date according to RECIST Criteria until progression was centrally confirmed: any participants with progressive disease ceased the treatment/assessment period and proceeded to the long-term follow-up period for evaluation of survival and long-term safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lutetium[177Lu] Oxodotreotide Injection | Experimental | Drug: Lutetium[177Lu] Oxodotreotide InjectionTreatment consisted of a cumulative administered radioactivity of 29.6 Giga Becquerel (GBq) (800 mCi) Lutetium[177Lu] Oxodotreotide Injection: Four administrations of 7.4 GBq (200 mCi). Concomitant amino acids were given with each administration for kidney protection. Lutetium[177Lu] Oxodotreotide Injection was administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity. In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, Octreotide s.c. rescue injections were allowed. |
| Octreotide LAR | Active comparator | Drug: Octreotide LAR60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died. In case participants experienced clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections were allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Aged 18 years or older.
- Histopathologically confirmed low and moderate grade (G1 or G2) unresectable locally advanced or metastatic GEP-NET (based on the fifth edition of the WHO classification and grading criteria for neuroendocrine tumors of the digestive system in 2019, to be centrally confirmed).
- Previously received fixed-dose Octreotide LAR (20-30 mg/3-4 weeks) for at least 12 weeks of continuous treatment with disease progression.
- Presence of disease progression prior to randomization (time point of disease progression limited to 1 year prior to randomization and no other antitumor therapy received after progression).
Key exclusion criteria (26 listed)
- Serum creatinine >150 μmol/L (1.7 mg/dL) or creatinine clearance <50 ml/min (Cockcroft Gault formula).
- Hemoglobin <80g/L, or white blood cell count <2.0×10^9/L, or platelets <75×10^9/L.
- Serum total bilirubin > 3 × upper limit of normal (ULN).
- Serum albumin <30g/L.
- alanine aminotransferase (ALT) or aspartate aminotransferase (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 InjectionAlso: 177Lu-DOTA0-Tyr3-OctreotateFour 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 | Lutetium[177Lu] Oxodotreotide Injection |
| Octreotide LARAlso: SANDOSTATIN LAR, Octreotide60 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. | Drug | Octreotide LAR |
Primary outcome
Progression Free Survival (PFS) assessed by BIRC
Time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Progression Free Survival (PFS) was defined as the time from randomization to documented centrally assessed disease progression, as evaluated by the Blinded Independent Review Committee (BIRC), or death due to any cause. If a participant had no centrally assessed progression and had not died at the time of the primary endpoint analysis, the participant was regarded as censored in the context of a time to event analysis at the date of last evaluable tumor assessment. Disease progression was determined by objective tumor response status using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).
15 secondary outcomes
Progression Free Survival (PFS) assessed by investigator
Time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Objective Response Rate (ORR) assessed by investigator
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Objective Response Rate (ORR) assessed by BIRC
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Duration of Response (DoR) assessed by investigator
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Duration of Response (DoR) assessed by BIRC
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Time to Tumour Progression (TTP) assessed by investigator
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Time to Tumour Progression (TTP) assessed by BIRC
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Disease Control Rate (DCR) assessed by investigator
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Disease Control Rate (DCR) assessed by BIRC
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
20-month Progression-Free Survival rate assessed by BIRC
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
20-month Progression-Free Survival rate assessed by investigator
Time frame: From date of randomization until date of progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Overall Survival (OS)
Time frame: From date of randomization until date of death from any cause up to final safety cut-off date reached，assessed up to approximately 60 months
Change From Baseline in the EORTC QLQ-C30 Questionnaire
Time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Change From Baseline in the EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
Time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months
Number of Participants With Adverse Events
Time frame: From informed consent signature through study completion reached at final safety cutoff date，assessed up to approximately 60 months
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 5 Sep 2025.
- Derived from this study: PubMed 41739362Liu F, Yang H, Zhang J, Li J, Qiao Y, Chen J, Song S. Relationship between absorbed dose and SUV derived from SPECT/CT imaging and dose-response in patients with neuroendocrine tumors treated with [(1)(7)(7)Lu]Lu-DOTA-TATE. EJNMMI Res. 2026 Feb 25;16(1):52. doi: 10.1186/s13550-026-01402-2.
- Derived from this study: PubMed 39607652Liu F, Li P, Xu J, Zhang J, Xu X, Chen Z, Qiao Y, Liang Y, Chen J, Song S. Radiation exposure and protection advice after [177Lu]Lu-DOTA-TATE therapy in China. EJNMMI Res. 2024 Nov 28;14(1):119. doi: 10.1186/s13550-024-01185-4.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jianming Xu principal investigator
Chinese PLA General Hospital
23 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 and Octreotide LAR in people with Neuroendocrine Tumors, run by Sinotau Pharmaceutical Group at 23 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 9 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: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) assessed by BIRC (time frame: From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first until Primary Analysis cutoff date reached，assessed up to approximately 34 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459844, which also lists 2 linked publications.
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 5 Sep 2025.