A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma
ConditionNeuroendocrine Carcinomas (NEC)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing GoBroad Hospital
About this trial
To explore the efficacy and safety of irinotecan liposome injection combined with 5-FU/LV in the treatment of advanced neuroendocrine carcinoma (NEC)
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Irinotecan Hydrochloride Liposome Injection
- 5-FU
- LV
Treatment groups
45 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing GoBroad Hospital
Lead sponsor
CSPC Ouyi Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov