Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
NCT Number: NCT06485739
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Neuroendocrine Tumors
Interventions: DRUG: Irinotecan liposomes combined with cisplatin/carboplatin
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2028-09-01

Summary:
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.

Primary Outcome Measures: Intracranial Objective response rate, Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with tumour response of Complete Response or Partial Response, will be assessed up to 1 years., Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Secondary Outcome Measures: Complete Response, According to the solid tumor response evaluation criteria 1.1 (RECIST 1.1) evaluated by researchers, it is defined as the number of patients (%) whose target lesions disappear and whose short diameter of all pathological lymph nodes (including target and non target nodules) must be reduced to\<10 mm, and will be evaluated within one year., Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.|Progression-free survival, Progression-free survival (PFS) is defined as the time from first treatment recorded until the date of disease progression based on investigator assessment., Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 3 years.|Overall Survival, Overall survival is defined as the time from beginning of treatment until death due to any cause and will be assessed up to 3 years., The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.|Safety/Adverse event, Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice., From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib