NCT06485739Not yet recruitingPhase 4
Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
The Efficacy and Safety of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Gastrointestinal Pancreatic Neuroendocrine Carcinoma: a Real-world Study
Source: ClinicalTrials.gov · Last updated 3 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 27 Jun 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT06485739
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 1 Jul 2024 to the primary completion date, 1 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has hypersensitivity to any investigational drug or its components;
- Has previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled within the past five years);
Other illness
- Uncontrollable systemic diseases (such as infection during the promotion period, uncontrollable hypertension, diabetes, etc.);
- Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen is positive and hepatitis B B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL);
- Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);
- Patients with other malignant tumors that require treatment;
Age
- Pregnant and lactating women, as well as patients of childbearing age who are unwilling to take contraceptive measures;
Other
- Patients with neuroendocrine tumors G1 and G2;
- Diagnosed as intestinal obstruction through imaging;
- The researchers determined that patients who are not suitable to participate in this study.
Who the study is looking for
- 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;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.