Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma (NCT06485739) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
20 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF);
* Age: ≥ 18 years old;
* Expected survival time ≥ 3 months;
* Patients with high-grade gastrointestinal pancreatic neuroendocrine tumors (NET G3) and neuroendocrine cancers (NECs) confirmed by histopathology;
* Have not undergone or undergone a systematic anti-tumor treatment in the past;
* According to RECIST 1.1 standard, patients must have at least one measurable diameter target lesion (tumor lesion CT scan length ≥ 10mm, lymph node lesion CT scan short diameter ≥ 15mm, scan layer thickness 5mm);
* ECOG score 0-2 points;
* Absolute neutrophil count (ANC) ≥ 1.5 x 10 \^ 9/L, platelet count ≥ 100 x 10 \^ 9/L, and hemoglobin count ≥ 90 g/L;
* Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal values (≤ 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin ≤ 1.5 times the upper limit of normal value (≤ 3 times the upper limit of normal value for patients with liver invasion);
* Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial period and 8 weeks after the last administration of the investigational drug;
Exclusion Criteria:
* Patients with neuroendocrine tumors G1 and G2;
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intracranial Objective response rate
Timeframe: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Trial details
NCT IDNCT06485739
SponsorFirst Affiliated Hospital Xi'an Jiaotong University