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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Irinotecan Hydrochloride Liposome Injection

    Drug

    Liposome irinotecan (70/50mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week

  • 5-FU

    Drug

    5-FU (2400mg/m\^2) will be administered by continuous infusion for 46 hours in a 2-week

  • LV

    Drug

    LV (400mg/m\^2) will be administered by intravenous infusion on day 1 in a 2-week

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 2 months

Secondary outcomes

1

overall survival (OS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 6 months
2

Progression-free survival (PFS)

To evaluate the efficacy of anti-tumor

Time frame
baseline up to approximately 12 months
3

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

To identify the incidence of AE and SAE in clinical trial

Time frame
From the initiation of the first dose to 14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing GoBroad Hospital

Lead sponsor

CSPC Ouyi Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: