drugset / Trial / NCT06485739

Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma

NCT06485739

Phase 4 Not yet recruiting 20 enrolled First Affiliated Hospital Xi'an Jiaotong University
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-07-01
Primary completion
2028-07-01
Completion
2028-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule
Subject Cisplatin Other / unclassified
Subject Irinotecan Small molecule 70 mg/m2