Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
NCT06485739 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-07-03
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.
Conditions
Interventions
- DRUG
-
Irinotecan liposomes combined with cisplatin/carboplatin
Irinotecan liposomes 70mg/m2,use on the first day of each cycle The dosage of cisplatin and carboplatin is determined by the researchers
Sponsors & Collaborators
-
First Affiliated Hospital Xi'an Jiaotong University
lead OTHER
Principal Investigators
-
EnXiao Li, PhD · First Affiliated Hospital of Xian Jiaotong University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2028-07-01
- Completion
- 2028-09-01
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