Status:
NOT_YET_RECRUITING
Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
Lead Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 irinoteca...
Detailed Description
Neuroendocrine tumors (NENs) are a type of tumor originating from stem cells and possessing neuroendocrine markers that can produce bioactive amines and/or peptide hormones. Due to their heterogeneity...
Eligibility Criteria
Inclusion
- 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
- Patients with neuroendocrine tumors G1 and G2;
- Has hypersensitivity to any investigational drug or its components;
- Diagnosed as intestinal obstruction through imaging;
- 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);
- 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);
- Pregnant and lactating women, as well as patients of childbearing age who are unwilling to take contraceptive measures;
- Patients with other malignant tumors that require treatment;
- The researchers determined that patients who are not suitable to participate in this study.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06485739
Start Date
July 1 2024
End Date
September 1 2028
Last Update
July 3 2024
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