Neuroendocrine Carcinomas (NEC)Phase 4NCT07014540
A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma
A Phase 4 study testing Irinotecan Hydrochloride Liposome Injection, 5-FU and LV in people with Neuroendocrine Carcinomas (NEC), run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU/LV in the treatment of advanced neuroendocrine carcinoma (NEC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Carcinomas (NEC)
- What is being tested?
- Irinotecan Hydrochloride Liposome Injection, 5-FU and LV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2027
- Phase
- Phase 4
- 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
- Age≥18 years
- Advanced poorly differentiated neuroendocrine carcinoma diagnosed by histopathology, grade 3 (PD-EP-NEC, G3), after excluding the primary lesion in the lungs, cancers with unknown primary lesions are also allowed
- Subjects who have failed at least the first-line standard treatment regimen in the past, recurrence within 6 months after the end of (new) adjuvant therapy is regarded as a failure of first-line treatment
- Has not received irinotecan treatment
- At least one measurable lesion，according to RECIST 1.1
- ECOG 0~1
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- The expected survival ≥3 months
- Having appropriate organ functions is defined as follows: those who need to complete hematological and blood biochemistry tests within 14 days before enrollment and meet the following conditions
- The absolute neutrophil count (ANC) was ≥1.5*10^9/L
- Hemoglobin ≥90g/dL
- Platelets (PLT) ≥100*10^9/L
- Total bilirubin <1.5 times the upper limit of normal value (ULN)
- Liver function Index (AST/ALT) chemical test <2.5 times the upper limit of normal value (ULN)
- Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance rate (CCr) ≥ 60mL/min, negative urine protein. For patients with urine protein ≥2+ at baseline, 24-hour urine collection should be conducted and the protein content in urine within 24 hours should be less than 1g
- Patients with brain metastases enrolled in the group must meet the following conditions: (1) No clinical symptoms related to brain metastases and no need for systemic corticosteroids or anticonvulsant drugs for treatment; (2) No risk of cerebral hemorrhage
- Male, female of childbearing age and their partners voluntarily adopted contraceptive measures considered effective by the researchers during the treatment and for at least three months after the last use of the study drug
- Be able to understand and voluntarily sign the written informed consent form, which must be signed before carrying out the research procedures specified in any trial
- Subjects fully understood and voluntarily participated in this study
Who cannot join
- Within 28 days before the first treatment with the study drug, biological therapy, chemotherapy, surgical treatment, radiotherapy (PRRT requires 56 days), immunotherapy and other clinical study drug treatments (except placebo) were received; Small molecule drug treatment was received within 5 half-lives (for example, 6 days for everolimus and 10 days for sunitinib)
- Adverse events caused by previous anti-tumor treatment (excluding alopecia) have not yet recovered (according to CTCAE. Version 5.0, with a severity level higher than level 1
- Known active, uncontrollable or symptomatic central nervous system metastases, cancerous meningitis or leptomeningeal diseases suggested by clinical symptoms, cerebral edema and/or progressive tumor growth. Patients with a history of central nervous system metastasis or spinal cord compression, if they have received definite local treatments (such as radiotherapy, stereotactic surgery) and are clinically stable, and have stopped anticonvulsants and steroids for at least 4 weeks before enrollment, are eligible to be enrolled in this study
- Known hemorrhagic constitution or disease
- Patients with any severe and/or uncontrolled diseases
- Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months, and severe uncontrolled arrhythmia;
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- Active or uncontrolled severe infections;
- Liver diseases such as liver cirrhosis, decompensated liver disease, and chronic hepatitis (i.e., positive for quantifiable HBV-DNA and/or HbsAg, and quantifiable HCV-RNA);
- Hypertension that cannot be controlled by medication is defined as a systolic blood pressure of ≥140mmHg or a diastolic blood pressure of ≥90mmHg
- There have been or are currently active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases, or unresected digestive tract tumors with active bleeding, or other conditions that may cause digestive tract bleeding or perforation as determined by the researcher
- Severe diarrhea (According to the NCI-CTCAE5.0 standard, grade 2 and above diarrhea: Compared with the baseline, the frequency of defecation increases by ≥4 times per day; Moderate to severe increase in the discharge from the stoma opening; Restrictions on daily living activities
- Those who have a history of deep vein thrombosis, pulmonary embolism or other serious thromboembolism within 6 months before the first administration of the study drug
- Subjects with serious injuries or non-healing wounds, or with unhealed fractures
- Combined with uncontrollable systemic diseases (such as unstable angina pectoris, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, history of severe pericardial diseases and other cardiovascular diseases；uncontrollable hypertension, diabetes, etc.
- Those who are known to be allergic or intolerant to therapeutic drugs or their excipients
- Patients who participated in other interventional clinical studies simultaneously
- Those with other malignant tumors requiring treatment
- The researchers judged the patients who were not suitable to participate in this study
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
Beijing GoBroad Hospital
Beijing, Beijing Municipality
Ming Lu, 15801292978
Yang Ke, 13592618724
About this study
Official title: Clinical Study on the Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV in the Treatment of Advanced Neuroendocrine Carcinoma
To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU/LV in the treatment of advanced neuroendocrine carcinoma (NEC)
Read the detailed description
- Irinotecan hydrochloride liposome injection combined with 5-FU/LV therapy in a 2-week treatment cycle ,until disease progresses or intolerable toxicity
Drug: Liposome irinotecan(50-70mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle
Drug: LV (400mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle
Drug: 5-FU(2400mg/m^2) will be administered by continuous infusion for 46 hours on day 1 in a 2-week treatment cycle
- Conditions
- Neuroendocrine Carcinomas (NEC)
- Being tested
- Irinotecan Hydrochloride Liposome Injection, 5-FU, LV
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan Hydrochloride Liposome InjectionDrug
Liposome irinotecan (70/50mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week
5-FUDrug
5-FU (2400mg/m^2) will be administered by continuous infusion for 46 hours in a 2-week
LVDrug
LV (400mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Irinotecan hydrochloride liposome injection combined with 5-FU/LV therapy in a 2-week treatment cycle , until disease progresses or intolerable toxicity Receives: Drug: Irinotecan Hydrochloride Liposome Injection; Drug: 5-FU; Drug: LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Measured: baseline up to approximately 2 months
Secondary outcomes (3)
overall survival (OS)
To evaluate the efficacy of anti-tumor
Measured: baseline up to approximately 6 months
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Measured: baseline up to approximately 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To identify the incidence of AE and SAE in clinical trial
Measured: From the initiation of the first dose to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start20 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine Carcinomas (NEC)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ming Lu, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014540
- Sponsor's protocol ID
- CSPC-DEY-NEC-BJ01
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV in the Treatment of Advanced Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07014540
- Acronym / sponsor ID
- CSPC-DEY-NEC-BJ01
- Conditions
- Neuroendocrine Carcinomas (NEC)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 2025 (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.
To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU/LV in the treatment of advanced neuroendocrine carcinoma (NEC)
Detailed description
- Irinotecan hydrochloride liposome injection combined with 5-FU/LV therapy in a 2-week treatment cycle ,until disease progresses or intolerable toxicity
Drug: Liposome irinotecan(50-70mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle
Drug: LV (400mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle
Drug: 5-FU(2400mg/m^2) will be administered by continuous infusion for 46 hours on day 1 in a 2-week treatment cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Irinotecan Hydrochloride Liposome Injection, Drug: 5-FU, Drug: LVIrinotecan hydrochloride liposome injection combined with 5-FU/LV therapy in a 2-week treatment cycle , until disease progresses or intolerable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age≥18 years
- Advanced poorly differentiated neuroendocrine carcinoma diagnosed by histopathology, grade 3 (PD-EP-NEC, G3), after excluding the primary lesion in the lungs, cancers with unknown primary lesions are also allowed
- Subjects who have failed at least the first-line standard treatment regimen in the past, recurrence within 6 months after the end of (new) adjuvant therapy is regarded as a failure of first-line treatment
- Has not received irinotecan treatment
- At least one measurable lesion，according to RECIST 1.1
Key exclusion criteria (18 listed)
- Within 28 days before the first treatment with the study drug, biological therapy, chemotherapy, surgical treatment, radiotherapy (PRRT requires 56 days), immunotherapy and other clinical study drug treatments (except placebo) were received; Small molecule drug treatment was received within 5 half-lives (for example, 6 days for everolimus and 10 days for sunitinib)
- Adverse events caused by previous anti-tumor treatment (excluding alopecia) have not yet recovered (according to CTCAE. Version 5.0, with a severity level higher than level 1
- Known active, uncontrollable or symptomatic central nervous system metastases, cancerous meningitis or leptomeningeal diseases suggested by clinical symptoms, cerebral edema and/or progressive tumor growth. Patients with a history of central nervous system metastasis or spinal cord compression, if they have received definite local treatments (such as radiotherapy, stereotactic surgery) and are clinically stable, and have stopped anticonvulsants and steroids for at least 4 weeks before enrollment, are eligible to be enrolled in this study
- Known hemorrhagic constitution or disease
- Patients with any severe and/or uncontrolled diseases
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 |
|---|---|---|
| Irinotecan Hydrochloride Liposome InjectionLiposome irinotecan (70/50mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week | Drug | Treatment group |
| 5-FU5-FU (2400mg/m^2) will be administered by continuous infusion for 46 hours in a 2-week | Drug | Treatment group |
| LVLV (400mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week | Drug | Treatment group |
Primary outcome
Objective response rate (ORR)
Time frame: baseline up to approximately 2 months
To evaluate the efficacy of anti-tumor
3 secondary outcomes
overall survival (OS)
Time frame: baseline up to approximately 6 months
Progression-free survival (PFS)
Time frame: baseline up to approximately 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From the initiation of the first dose to 14 days
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 11 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irinotecan Hydrochloride Liposome Injection, 5-FU and LV in people with Neuroendocrine Carcinomas (NEC), run by Beijing GoBroad Hospital 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 18 inclusion and 18 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: opening soon, as of the sponsor's last update on 11 Jun 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ming Lu (15801292978, minglupku@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) (time frame: baseline up to approximately 2 months). 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 11 Jun 2025.