Neuroendocrine TumorsPhase 2NCT05894486
Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors
A Phase 2 study testing Lutetium[177Lu] Oxodotreotide Injection in people with Neuroendocrine Tumors, run by Peking University at 1 site in China.
Trial summary
his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium[177Lu] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuroendocrine Tumors
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 5 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Ability to understand and willingness to sign a written informed consent document.
- Aged 18-75 years.
- Histopathologically confirmed G2 or G3 unresectable locally advanced or metastatic GEP-NET, Ki67 index ≥10 and ≤ 55%. (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).
- Subjects have not received prior systemic antitumor therapy for the current stage of NET.
- Presence of at least 1 measurable site of disease (based on RECIST 1.1).
- All target lesions (based on RECIST 1.1) at baseline must be confirmed as growth inhibitor 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 3 months 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 <2.0×109/L, or platelets <75×109/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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- Pregnant or lactating females.
- Received peptide receptor radionuclide therapy(PRRT) prior to randomization.
- Received the following treatments within 4 weeks prior to treatment, including but not limited to surgery (except biopsy), radical radiotherapy, hepatic artery interventional embolization, cryoablation of liver metastases, or radiofrequency ablation.
- Received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy, chemotherapy within 4 weeks prior to randomization.
- Toxicity of prior antitumor therapy has not returned to ≤ grade 1 levels (except for alopecia).
- Received external beam radiation therapy for bone metastases within 2 weeks prior to treatment.
- More than 25% of bone marrow with prior external radiation radiotherapy.
- 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.
- uncontrolled diabetes mellitus, including baseline fasting glucose > 2 x ULN.
- 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.
- 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 clinically significant active infection, including Positive human immunodeficiency virus (HIV) antibody.
- Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and positive for HBV DNA (≥1×104 copies/ml or judged positive by research center criteria), or positive for hepatitis C virus (HCV) antibodies.
- Participated in other drug clinical trials within 4 weeks prior to the first treatment and received treatment with the corresponding trial drug.
- 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.
- Subjects who, in the judgment of the investigator, are suspected of having a disease or condition that makes them unsuitable for the study drug disease or condition.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Ming Lu, professor, 010-88196561, qiminglu_mail@126.com
Ming Lu, professor
About this study
Official title: Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Inoperable Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors
his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium[177Lu] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, 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 assigned to treatment with Lutetium[177Lu] Oxodotreotide Injection. Objective tumor assessment in both groups was performed every 12+/-1 weeks from the first treatment date according to RECIST 1.1 Criteria until progression.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Lutetium[177Lu] Oxodotreotide Injection
- Keywords
- PRRT, Lutetium[177Lu]
- 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
Lutetium[177Lu] Oxodotreotide InjectionFour 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
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants
Measured: Up to 2 years
Secondary outcomes (3)
Incidence of Treatment-Related Adverse Events
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.
Measured: Until 30 days after the last treatment
Progression-free Survival (PFS) per RECIST 1.1 in all participants
PFS is defined as the time from the date of first dose to the first documented disease
Measured: Up to 2 years
Disease control rate(DCR)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start5 Jun 2023 (estimated)
- Primary completion5 Jun 2025 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894486
- Sponsor's protocol ID
- XT-XTR008-2-01
- Status last verified
- May 2023
- First submitted
- 30 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Efficacy and Safety of 177Lu-Dotatate in the First-line Treatment of Inoperable Patients With Locally Advanced or Metastatic, Somatostatin Receptor-positive G2 or G3 Gastroenteropancreatic Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT05894486
- Acronym / sponsor ID
- XT-XTR008-2-01
- Conditions
- Neuroendocrine Tumors
- Keywords
- PRRT, Lutetium[177Lu]
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 5 Jun 2023 (estimated)
- Primary completion
- 5 Jun 2025 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 8 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.
his was a single-center, single-arm phase II study evaluate the efficacy and safety of Lutetium[177Lu] Oxodotreotide Injection in the first-line treatment of unresectable or metastatic, progressive, G2 or G3, 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 assigned to treatment with Lutetium[177Lu] Oxodotreotide Injection. Objective tumor assessment in both groups was performed every 12+/-1 weeks from the first treatment date according to RECIST 1.1 Criteria until 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 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Aged 18-75 years.
- Histopathologically confirmed G2 or G3 unresectable locally advanced or metastatic GEP-NET, Ki67 index ≥10 and ≤ 55%. (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).
- Subjects have not received prior systemic antitumor therapy for the current stage of NET.
- Presence of at least 1 measurable site of disease (based on RECIST 1.1).
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 <2.0×109/L, or platelets <75×109/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-OctreotateLutetium[177Lu] Oxodotreotide InjectionFour 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 |
Primary outcome
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants
Time frame: Up to 2 years
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants
3 secondary outcomes
Incidence of Treatment-Related Adverse Events
Time frame: Until 30 days after the last treatment
Progression-free Survival (PFS) per RECIST 1.1 in all participants
Time frame: Up to 2 years
Disease control rate(DCR)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lutetium[177Lu] Oxodotreotide Injection in people with Neuroendocrine Tumors, run by Peking University 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 8 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: status not confirmed, as of the sponsor's last update on 8 Jun 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Lu, professor (86-10-88196561, qiminglu_mail@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants (time frame: Up to 2 years). 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 8 Jun 2023.