Not Yet RecruitingPhase 4

A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma

China45 participantsStarted 2025-06-20

Plain-language summary

To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU/LV in the treatment of advanced neuroendocrine carcinoma (NEC)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. 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

Exclusion criteria

✕. 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;
✕. 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);

What they're measuring

Objective response rate (ORR)

Timeframe: baseline up to approximately 2 months

Trial details

NCT IDNCT07014540

SponsorBeijing GoBroad Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Ming Lu

15801292978 minglupku@126.com

View on ClinicalTrials.gov More Neuroendocrine Carcinomas (NEC) trials