Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT06485739
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

Study Details

This study is a real-world clinical study. It is expected to include 20 patients with first-line and second-line gastrointestinal pancreatic neuroendocrine carcinoma who will be treated with irinotecan liposomes combined with cisplatin or carboplatin regimen. The research unit is the First Affiliated Hospital of Xi'an Jiaotong University. The study includes a screening period (within 28 days), a treatment period (planned for 6 cycles), and a follow-up period (safety follow-up and PFS follow-up). The subjects signed an informed consent form and underwent baseline examination during the screening period. Patients who met the inclusion and exclusion criteria entered the treatment period. All subjects completed the relevant examinations specified in the protocol during the treatment process to observe safety, tolerance, and efficacy. The same subject only received one dosing plan during the study period. After the treatment period ends, enter the follow-up period.

Key Dates

Start date
Jul 1, 2024
Status verified
Jun 2024
Primary completion
Jul 1, 2028
Completion
Sep 1, 2028

Study Design

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

Arms

  • Experimental: Irinotecan liposome combined administration group
    The combination of irinotecan liposomes and cisplatin or carboplatin regimen is recommended for treatment, with a recommended dose of 70mg/m2 for irinotecan liposomes. For UGT1A1 \* 28 homozygous patients, the initial dose of irinotecan liposomes is adjusted to 50mg/m2. If the patient tolerates during the first treatment cycle, the dose can be adjusted to 70mg/m2 for subsequent treatment cycles; Every 4 weeks is a treatment cycle, with 6 cycles of treatment. If the researcher determines that the patient can continue to benefit from 6 cycles of treatment, the treatment will continue until 8 cycles;

Primary Outcome Measure

Intracranial Objective response rate [ Time Frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years. ]

Central Contacts

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