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NCT06485739

PHASE4

Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma

Sponsor: First Affiliated Hospital Xi'an Jiaotong University

View on ClinicalTrials.gov

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.

Official title: The Efficacy and Safety of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Gastrointestinal Pancreatic Neuroendocrine Carcinoma: a Real-world Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-07-01

Completion Date

2028-09-01

Last Updated

2024-07-03

Healthy Volunteers

Conditions

Neuroendocrine Tumors

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

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; * 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.