Neuroendocrine TumorsPhase 4NCT06485739
Irinotecan Liposomes for the Treatment of Neuroendocrine Carcinoma
A Phase 4 study testing Irinotecan liposomes combined with cisplatin/carboplatin in people with Neuroendocrine Tumors, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Irinotecan liposomes combined with cisplatin/carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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;
Who cannot join
- 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);
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
XuYuan Dong, PhD contact
About this study
Official title: The Efficacy and Safety of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Gastrointestinal Pancreatic Neuroendocrine Carcinoma: a Real-world Study
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.
Read the 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 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.
- Conditions
- Neuroendocrine Tumors
- Being tested
- Irinotecan liposomes combined with cisplatin/carboplatin
- Keywords
- Irinotecan liposomes, Neuroendocrine tumors
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan liposomes combined with cisplatin/carboplatinDrug
Also called Irinotecan liposomes group
Irinotecan liposomes 70mg/m2，use on the first day of each cycle The dosage of cisplatin and carboplatin is determined by the researchers
| Study group | Role | What they receive |
|---|---|---|
| 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; Receives: Drug: Irinotecan liposomes combined with cisplatin/carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li EnXiao, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- EnXiao Li, PhD, Study director, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485739
- Sponsor's protocol ID
- 2024-101
- Status last verified
- Jun 2024
- First submitted
- 27 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Gastrointestinal Pancreatic Neuroendocrine Carcinoma: a Real-world Study
- ClinicalTrials.gov ID
- NCT06485739
- Acronym / sponsor ID
- 2024-101
- Conditions
- Neuroendocrine Tumors
- Keywords
- Irinotecan liposomes, Neuroendocrine tumors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan liposome combined administration group | Experimental | Drug: Irinotecan liposomes combined with cisplatin/carboplatinThe 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; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (10 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan liposomes combined with cisplatin/carboplatinAlso: Irinotecan liposomes groupIrinotecan liposomes 70mg/m2，use on the first day of each cycle The dosage of cisplatin and carboplatin is determined by the researchers | Drug | Irinotecan liposome combined administration group |
Primary outcome
Intracranial Objective response rate
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.
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.
4 secondary outcomes
Complete Response
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
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
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
Time frame: From the recorded first dose of Furmonertinib to 4 weeks after the recorded last dose of Furmonertinib
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
XuYuan Dong, PhD contact
EnXiao Li, PhD study director
First Affiliated Hospital of Xian Jiaotong University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Irinotecan liposomes combined with cisplatin/carboplatin in people with Neuroendocrine Tumors, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EnXiao Li, PhD (18991232168, doclienxiao@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial Objective response rate (time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.