Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET (NCT05385861) | Clinical Trial Compass
By InvitationPhase 1/2
Nal-IRI (ONIVYDE® ) and Carboplatin in Patients With Advanced or Metastatic GEP-NET
Taiwan52 participantsStarted 2025-08-14
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
MTD and RP2D
Timeframe: 3 Years
2
tumor response rate
Timeframe: 3 Years
Trial details
NCT IDNCT05385861
SponsorNational Health Research Institutes, Taiwan
✕. 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.