A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma

Sponsor
Beijing GoBroad Hospital
Study ID
NCT07014540
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Neuroendocrine Carcinomas (NEC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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

Key Dates

Start date
Jun 20, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Irinotecan hydrochloride liposome injection combined with 5-FU/LV therapy in a 2-week treatment cycle , until disease progresses or intolerable toxicity

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: baseline up to approximately 2 months ]

Central Contacts

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