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.
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 and inertness, they have been defined as "carcinoids". Due to differences in origin, pathological grading, and treatment methods, NEN has different clinical manifestations and prognosis. Although NEN still meets the definition of rare disease, its incidence rate has increased significantly worldwide in the past decades. In the United States, the incidence rate of NEN in 2012 was 6.98/100000, about seven times the incidence rate reported in 1973 (1.09/100000). Among them, gastrointestinal and pancreatic neuroendocrine tumors (GEP NENs) are the most common type of NEN, accounting for 67.5% of all NEN cases. They mainly occur in the digestive tract or pancreas and can produce amine substances and peptide hormones such as glucagon, insulin, gastrin, or adrenocorticotropic hormone (ACTH). We analyzed the data of ordinary irinotecan in first-line and second-line treatment of GEP-NEC and found that a prospective Phase II clinical study included 66 patients with advanced GEP-NEC. The results showed that the efficacy of the first line treatment using EP and IP regimens was equivalent, with an effective rate of over 40%. However, the efficacy of the second-line FOLFOX and FOLFIRI regimens is not ideal. Studies by HENTIC et al. have shown that the response rate of GEP-NEC to the FOLFIRI regimen is 31%, but the PFS is only 4 months; DU et al. also found that the median PFS of the FOLFIRI regimen was only 6.5 months in 11 patients with gastrointestinal NEC. The current research results on the FOLFOX regimen are similar. If there are studies showing that FOLFOX is used as a second-line regimen to treat 12 patients with advanced GEP-NEC, the median PFS is 4.5 months. HEETFELD et al. observed the efficacy of the FOLFIRI/FOLFOX regimen in GEP-NEC patients on the second or third line, and the results also showed a median PFS of 3.0 months and 2.5 months for the second and third line groups, respectively. Overall, the second-line treatment regimens recommended by the NCCN guidelines have not shown ideal efficacy and PFS in GEP-NEC. Based on the literature review above and the birth of independently developed irinotecan liposomes by Shiyao, we plan to conduct a real-world study on the combination of irinotecan liposomes and platinum based treatment of gastrointestinal neuroendocrine carcinoma. The aim is to explore the efficacy and safety of a combination of irinotecan liposomes and platinum based chemotherapy regimen in first-line and second-line patients with gastrointestinal neuroendocrine carcinoma, providing better clinical evidence of efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Irinotecan liposomes 70mg/m2，use on the first day of each cycle The dosage of cisplatin and carboplatin is determined by the researchers
Intracranial Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with tumour response of Complete Response or Partial Response, will be assessed up to 1 years.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Complete Response
According to the solid tumor response evaluation criteria 1.1 (RECIST 1.1) evaluated by researchers, it is defined as the number of patients (%) whose target lesions disappear and whose short diameter of all pathological lymph nodes (including target and non target nodules) must be reduced to\<10 mm, and will be evaluated within one year.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
Progression-free survival
Progression-free survival (PFS) is defined as the time from first treatment recorded until the date of disease progression based on investigator assessment.
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 3 years.
Overall Survival
Overall survival is defined as the time from beginning of treatment until death due to any cause and will be assessed up to 3 years.
Time frame: The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.
Safety/Adverse event
Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice.
Time frame: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib
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