Status:
ENROLLING_BY_INVITATION
Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
Conditions:
GEP-NET
Eligibility:
All Genders
20-80 years
Phase:
PHASE1
PHASE2
Brief 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 neuroendocri...
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-limitin...
Eligibility Criteria
Inclusion
- 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.
- 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).
Exclusion
- 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.
- 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).
Key Trial Info
Start Date :
August 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05385861
Start Date
August 14 2025
End Date
December 31 2025
Last Update
August 15 2025
Active Locations (6)
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1
Chang-Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
3
Chang Gung Memorial Hospital (Lin-Kou),
Linkou District, Taiwan
4
China Medical University Hospital
Taichung, Taiwan