Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma

NCT06485739 | Not Yet Recruiting Phase 4

• 1 other identifier: 2024-101
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Neuroendocrine Tumors

Keywords

Irinotecan liposomes; Neuroendocrine tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.

Secondary Outcomes (4)

• Complete Response

  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) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 3 years.

• Overall Survival

  The time from beginning of treatment until death due to any cause and will be assessed up to 3 years.

• Safety/Adverse event

  From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib

Study Arms (1)

Irinotecan liposome combined administration group

EXPERIMENTAL

The combination of irinotecan liposomes and cisplatin or carboplatin regimen is recommended for treatment, with a recommended dose of 70mg/m2 for irinotecan liposomes. For UGT1A1 \* 28 homozygous patients, the initial dose of irinotecan liposomes is adjusted to 50mg/m2. If the patient tolerates during the first treatment cycle, the dose can be adjusted to 70mg/m2 for subsequent treatment cycles; Every 4 weeks is a treatment cycle, with 6 cycles of treatment. If the researcher determines that the patient can continue to benefit from 6 cycles of treatment, the treatment will continue until 8 cycles;

Drug: Irinotecan liposomes combined with cisplatin/carboplatin

Interventions

Irinotecan liposomes combined with cisplatin/carboplatin DRUG

Irinotecan liposomes 70mg/m2，use on the first day of each cycle The dosage of cisplatin and carboplatin is determined by the researchers

Also known as: Irinotecan liposomes group

Irinotecan liposome combined administration group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals

Study Officials

• EnXiao Li, PhD

  First Affiliated Hospital of Xian Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

EnXiao Li, PhD

CONTACT

18991232168; doclienxiao@sina.com

XuYuan Dong, PhD

CONTACT

15332304217

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical professor

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share