GEP-NETPhase 1/2NCT05385861
Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET
A Phase 1/2 study testing nanoliposomal irinotecan plus carboplatin in people with GEP-NET, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.
Trial summary
The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- GEP-NET
- What is being tested?
- nanoliposomal irinotecan plus carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 6 sitesTaiwan
- Study dates
- 14 Aug 2025to 31 Dec 2025
- Phase
- Phase 1/2
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed locally advanced or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma.
- patients either are chemotherapy-naive or had received adjuvant chemotherapy > 6 months before recurrence.
- at least one measurable lesion according to the RECIST version 1.1..
- patients were aged 20 to 80 years with ECOG performance status of 0 to 1.
- patients had a life expectancy ≥ 3 months.
- patients had adequate renal function with defined as serum creatinine ≤ 2 times the upper limit of normal (ULN) or eGFR (calculated Ccr) ≥ 45 mL/min.
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- patients had adequate hepatic function, defined as total bilirubin ≤ 1.5 times the ULN and alanine aminotransferase ≤ 2.5 the ULN and ≤ 5 times the ULN within the setting of liver metastases.
- patients had adequate bone marrow function, defined as an absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 9 g/dL.
- Normal ECG or abnormal ECG without any clinical significantly findings.
- Able to understand and sign an informed consent (or have a legal representative who is able to do so).
Who cannot join
- a history of palliative chemotherapy or disease recurrence < 6 months from the time of last adjuvant chemotherapy and/or radiotherapy.
- known hypersensitivity to liposome product, irinotecan or carboplatin.
- receipt of major surgery within the past 4 weeks before study enrollment.
- With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea > grade 2.
- concurrent severe infection with intravenous systemic antibiotics treatment.
- severe, uncontrolled medical condition including severe liver disease, heart disease, uncontrolled diabetes or hypertension, or pulmonary disease.
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- another previous malignancy diagnosed within the past 5 years except for nonmelanoma skin cancer or stage I cervical cancer.
- active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti-convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable.
- psychiatric illness or social situation that would preclude study compliance
- women with pregnant or breast feeding (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative).
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Taiwan6 sites
Chang-Gung Memorial Hospital, Kaohsiung
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital (Lin-Kou),
Linkou District
China Medical University Hospital
Taichung
National Cheng-Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
About this study
Official title: A Phase I/II Study of Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinoma
The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy.
Read the detailed description
Eligible patients will be treated into two cohorts.
In adaptive phase 1 cohort:
Six patients will be enrolled in safety run-in cohort of dose level 0. If less than 2 patients experience dose-limiting toxicity (DLT) in dose level 0, dose level 1 will be tested. However, if more than 1 patients experience DLT in dose level 0, dose level -1 will be tested. The MTD at which no more than 1 of the 6 patients experience DLT will be determined for the phase 2 cohort. Otherwise, additional 6 patients will be tested in the dose level -1. Based on results from safety run-in cohort, PR2D will be determined. The evaluable patients in RP2D cohort will be incorporated into phase 2 cohort for final analysis.
Dose in phase 1 cohort:
Dose level 1= onivyde 100 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level 0= onivyde 80 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level -1= onivyde 60 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Carboplatin dose (mg) is calculated by the Calvert formula: AUC x (eGFR + 25). Cockcroft-Gault equation: eGFR (calculated Ccr)= [(140-age) x weight x 0.85 (if female)] / (72 x serum Cr). The maximum eGFR for dose calculation is 125 ml/min.
The definition of DLT:
Following toxicities occur during the first cycle of the combination chemotherapy with nal-IRI (ONIVYDE®) and carboplatin will be considered as DLTs. Toxicities are assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
- Grade 4 neutropenia (ANC < 500/μL) ≥3 days' duration under primary G-CSF support
- Grade 3 or higher neutropenia (ANC < 1,000/μL) with concurrent active infection requiring IV antibiotics treatment
- Grade 4 thrombocytopenia (platelet counts < 25,000/μL)
- Grade 3 thrombocytopenia (platelet counts < 50,000/μL) associated with active bleeding that transfusion is required
- Any grade 3 or higher treatment-related non-hematologic toxicity (except for anorexia/nausea, vomiting, and asthenia/fatigue)
- Any adverse drug reactions lead to more than 3 weeks delay
In Phase 2 Cohort Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria.
Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) every 6 weeks.
Adverse events (AEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Patients sign additional consent to participate in the next generation sequencing study will be required to have extra tissue samplings at the study entry.
A follow-up visit is required approximately 30 days after treatment discontinuation. Overall survival status will be followed by clinic visit or by phone every 3 months until death or the maximum of 3 years, whichever occurs first.
- Conditions
- GEP-NET
- Being tested
- nanoliposomal irinotecan plus carboplatin
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoliposomal irinotecan plus carboplatinDrug
Also called Phase 1 cohort, Phase 2 Cohort
Dose in phase 1 cohort:
Dose level 1= nanoliposomal irinotecan 100 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk
Dose level 0= nanoliposomal irinotecan 80 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk
Dose level -1= nanoliposomal irinotecan 60 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk
Carboplatin dose (mg) is calculated by the Calvert formula: AUC x (eGFR + 25). Cockcroft-Gault equation: eGFR (calculated Ccr)= [(140-age) x weight x 0.85 (if female)] / (72 x serum Cr). The maximum eGFR for dose calculation is 125 ml/min.
In Phase 2 Cohort Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| nal-IRI (ONIVYDE®) and Carboplatin | Experimental | nal-IRI (ONIVYDE®) and Carboplatin Receives: Drug: nanoliposomal irinotecan plus carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD and RP2D
- in phase 1 cohort, to determine MTD (maximum tolerated dose) and recommended phase 2 dose (RP2D)
Measured: 3 Years
tumor response rate
- in phase 2 cohort, to assess the objective tumor response rate
Measured: 3 Years
Secondary outcomes (2)
PFS and OS
- to assess other efficacy variables, including disease control rate, progression free survival (PFS), and overall survival (OS)
Measured: 3 Years
To explore the treatment-related adverse events as assessed by CTCAE v5.0
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start14 Aug 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GEP-NETStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- an investigator-initiated, single-arm phase 1/2 study
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Tsang-Wu Liu, Study director, Taiwan Cooperative Oncology Group, NHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385861
- Sponsor's protocol ID
- T2222
- Status last verified
- Aug 2025
- First submitted
- 9 May 2022
- Last updated
- 15 Aug 2025
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT05385861
- Acronym / sponsor ID
- T2222
- Conditions
- GEP-NET
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan, Chang Gung Memorial Hospital, China Medical University Hospital, National Cheng-Kung University Hospital, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 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.
The current study is an investigator-initiated, single-arm phase 1/2 study that enrolled patients with advanced or recurrent and/or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma for the treatment of nal-IRI (ONIVYDE®) plus carboplatin as the first-line chemotherapy.
Detailed description
Eligible patients will be treated into two cohorts.
In adaptive phase 1 cohort:
Six patients will be enrolled in safety run-in cohort of dose level 0. If less than 2 patients experience dose-limiting toxicity (DLT) in dose level 0, dose level 1 will be tested. However, if more than 1 patients experience DLT in dose level 0, dose level -1 will be tested. The MTD at which no more than 1 of the 6 patients experience DLT will be determined for the phase 2 cohort. Otherwise, additional 6 patients will be tested in the dose level -1. Based on results from safety run-in cohort, PR2D will be determined. The evaluable patients in RP2D cohort will be incorporated into phase 2 cohort for final analysis.
Dose in phase 1 cohort:
Dose level 1= onivyde 100 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level 0= onivyde 80 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level -1= onivyde 60 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Carboplatin dose (mg) is calculated by the Calvert formula: AUC x (eGFR + 25). Cockcroft-Gault equation: eGFR (calculated Ccr)= [(140-age) x weight x 0.85 (if female)] / (72 x serum Cr). The maximum eGFR for dose calculation is 125 ml/min.
The definition of DLT:
Following toxicities occur during the first cycle of the combination chemotherapy with nal-IRI (ONIVYDE®) and carboplatin will be considered as DLTs. Toxicities are assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
- Grade 4 neutropenia (ANC < 500/μL) ≥3 days' duration under primary G-CSF support
- Grade 3 or higher neutropenia (ANC < 1,000/μL) with concurrent active infection requiring IV antibiotics treatment
- Grade 4 thrombocytopenia (platelet counts < 25,000/μL)
- Grade 3 thrombocytopenia (platelet counts < 50,000/μL) associated with active bleeding that transfusion is required
- Any grade 3 or higher treatment-related non-hematologic toxicity (except for anorexia/nausea, vomiting, and asthenia/fatigue)
- Any adverse drug reactions lead to more than 3 weeks delay
In Phase 2 Cohort Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria.
Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) every 6 weeks.
Adverse events (AEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Patients sign additional consent to participate in the next generation sequencing study will be required to have extra tissue samplings at the study entry.
A follow-up visit is required approximately 30 days after treatment discontinuation. Overall survival status will be followed by clinic visit or by phone every 3 months until death or the maximum of 3 years, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- an investigator-initiated, single-arm phase 1/2 study
| Arm | Type | Receives |
|---|---|---|
| nal-IRI (ONIVYDE®) and Carboplatin | Experimental | Drug: nanoliposomal irinotecan plus carboplatinnal-IRI (ONIVYDE®) and Carboplatin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically confirmed locally advanced or metastatic gastroenteropancreatic poorly differentiated neuroendocrine carcinoma.
- patients either are chemotherapy-naive or had received adjuvant chemotherapy > 6 months before recurrence.
- at least one measurable lesion according to the RECIST version 1.1..
- patients were aged 20 to 80 years with ECOG performance status of 0 to 1.
- patients had a life expectancy ≥ 3 months.
Key exclusion criteria (10 listed)
- a history of palliative chemotherapy or disease recurrence < 6 months from the time of last adjuvant chemotherapy and/or radiotherapy.
- known hypersensitivity to liposome product, irinotecan or carboplatin.
- receipt of major surgery within the past 4 weeks before study enrollment.
- With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea > grade 2.
- concurrent severe infection with intravenous systemic antibiotics treatment.
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 |
|---|---|---|
| nanoliposomal irinotecan plus carboplatinAlso: Phase 1 cohort, Phase 2 CohortDose in phase 1 cohort: Dose level 1= nanoliposomal irinotecan 100 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level 0= nanoliposomal irinotecan 80 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Dose level -1= nanoliposomal irinotecan 60 mg/m2 plus carboplatin AUC=4, intravenously both on day 1, q3wk Carboplatin dose (mg) is calculated by the Calvert formula: AUC x (eGFR + 25). Cockcroft-Gault equation: eGFR (calculated Ccr)= [(140-age) x weight x 0.85 (if female)] / (72 x serum Cr). The maximum eGFR for dose calculation is 125 ml/min. In Phase 2 Cohort Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria. | Drug | nal-IRI (ONIVYDE®) and Carboplatin |
Primary outcome
MTD and RP2D
Time frame: 3 Years
• in phase 1 cohort, to determine MTD (maximum tolerated dose) and recommended phase 2 dose (RP2D)
tumor response rate
Time frame: 3 Years
• in phase 2 cohort, to assess the objective tumor response rate
2 secondary outcomes
PFS and OS
Time frame: 3 Years
To explore the treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 3 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 15 Aug 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.
Tsang-Wu Liu study director
Taiwan Cooperative Oncology Group, NHRI
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nanoliposomal irinotecan plus carboplatin in people with GEP-NET, run by National Health Research Institutes, Taiwan at 6 sites in Taiwan.
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 10 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
MTD and RP2D (time frame: 3 Years). 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 15 Aug 2025.