Gastrointestinal Neuroendocrine TumorPhase 2NCT03963193
Etoposide/Cisplatin Compared With Irinotecan/Cisplatin for Advanced Gastrointestinal Neuroendocrine Tumor G3 Type
A Phase 2 study testing Etoposide and Irinotecan in people with Gastrointestinal Neuroendocrine Tumor, run by Henan Cancer Hospital.
Trial summary
The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Neuroendocrine Tumor
- What is being tested?
- Etoposide and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 1 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. 18-75 years old, male or female. 2. Confirmed non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type patients by histopathological and imaging examinations.
- 3. ECOG performance status 0-1. 4. Life expectancy ≥ 12 weeks. 5. A histological specimen can be provided for secondary testing. 6. According to the evaluation criteria of solid tumor efficacy (RESIST 1.1), there should be at least one measurable lesion (empty organs such as esophagus and stomach cannot be taken as the measurable lesion), and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area is also selected as the target lesion if the lesion progression is confirmed).
- 7. Never received system treatment before, including cytotoxic drugs. For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs can be screened.
- 8. The main organ function meets the following criteria within 7 days before treatment:
- Blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g/L, the absolute value of neutrophils (ANC) ≥ 1.5 x 10^9/L, platelet (PLT) ≥ 80 x 10^9/L.
- Biochemical examinations must meet the following criteria: total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN, serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance (CCR) ≥ 60 mL/min.
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- Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
- 9. Fertile men and women must use effective contraception during the study period and within 6 months after the end of the study.
- 10. Volunteered to participate in the study and signed an informed consent form.
Who cannot join
- 1.Patients exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in site, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor infiltrating basement membrane)); Patients with rapid progress within 3 months.
- 2. History of gastrointestinal perforation and/or fistula within 6 months prior to the first administration.
- 3. Patients who had received radiotherapy for tumor target lesions within 4 weeks before enrollment.
- 4. History of immunodeficiency disease, including HIV positive and other acquired or congenital immunodeficiency diseases.
- 5. Allergic reactions and drug adverse reactions:
- A history of allergy to the ingredients of the study drug;
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- Any contraindication to any study drug (etoposide, irinotecan and cis-platinum) in the chemotherapy regimen.
- 6. Significantly malnourished patients. Exclusion is performed if the patient is receiving intravenous fluids or is required to be hospitalized for continuous infusion therapy. Patients with good nutrition control ≥ 28 days can be enrolled before randomization.
- 7. Any severe and/or uncontrolled disease, including:
- Patients with hypertension whose blood can't be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).
- Grade 1 or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc ≥ 480 ms) or grade 2 and above congestive heart failure according to New York Heart Association (MYHA) classification.
- Severe or uncontrolled disease or active infection (≥ CTC AE grade 2), which the investigators believe may increase the risk associated with patient participation and drug administration.
- Renal failure requiring hemodialysis or peritoneal dialysis.
- Patients of diabetes who have poor glycemic control (fasting blood glucose (FBG) > 10 mmol/L).
- Patients of seizures requiring treatment. 8. Patients with gastrointestinal disease such as intestinal obstruction (including incomplete intestinal obstruction) or those who may meet gastrointestinal bleeding, perforation obstruction.
- 9. Patients who underwent surgical treatment, incision biopsy or significant traumatic injury within 28 days prior to enrollment.
- 10. Any bleeding event ≥ CTC AE grade 3 or unhealed wounds, ulcers or fractures in 4 weeks prior to enrollment.
- 11. Arterial/venous thrombosis events within 3 months, such as cerebrovascular accidents (including transient ischemic attacks), deep venous thrombosis and pulmonary embolism.
- 12. Patients who prepared or accepted previously allogeneic organ or bone marrow transplantation, including liver transplantation.
- 13. Concomitant disease that seriously harms the patient's safety or affects the patient's completion of the study according to the investigator's judgment.
- 14. Patients cannot provide histological specimens for secondary test. 15. Patients who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder.
- 16. Urine routine showed urinary protein ≥ 2 + and 24-hour urine protein quantitation > 1.0 g.
- 17. Patients with brain metastases. 18. Patients who have participated in other anti-tumor drug clinical trials within 4 weeks.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase II Trial of Etoposide Plus Cisplatin Compared With Irinotecan Plus Cisplatin for First-line Treatment of Non-primary Pancreatic Metastatic and/or Unresectable Gastrointestinal Neuroendocrine Tumor G3 Type
The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
Read the detailed description
The prognosis of gastrointestinal neuroendocrine tumor G3 type patients who cannot be surgically resected is poor. The median overall survival (OS) is only 6-10 months, and the 3-year survival rate is less than 10%. Among the neuroendocrine tumors of the digestive system, only pancreatic neuroendocrine tumor has a standard treatment strategy, and there is a lack of prospective clinical research data on other gastrointestinal neuroendocrine tumors. According to the chemotherapy regimen of small cell lung cancer, etoposide plus cisplatin or irinotecan plus cisplatin is the choice of rescue therapy for advanced non-surgical or metastatic neuroendocrine tumor G3 type. However, prospective studies are needed to confirm whether there are differences in efficacy and safety between the two chemotherapy regimens. The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
- Conditions
- Gastrointestinal Neuroendocrine Tumor
- Being tested
- Etoposide, Irinotecan
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtoposideDrug
Also called Cisplatin
Etoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days.
IrinotecanDrug
Also called Cisplatin
Irinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Etoposide plus Cisplatin | Experimental | Etoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over. Receives: Drug: Etoposide |
| Irinotecan plus Cisplatin | Experimental | Irinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over. Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
To compare objective response rate of the two arms from date of anti-cancer therapy until progression
Measured: up to 2 years
Progression-free Survival (PFS)
From the first day of treatment until the date of first documented progression or date of death from any cause
Measured: up to 2 years
Secondary outcomes (3)
Overall survival (OS)
From the first day of treatment to death or last survival confirm date
Measured: up to 2 years
Number of Participants with Treatment-related Adverse Events
Treatment-related adverse events will be assessed by CT CAE v4.0
Measured: up to 2 years
Assessment of Health-related quality of life
Quality of Life Questionnaire (QLQ-C30) will be evaluated since treatment begins. At the end of the trail, the differences between the two indicators will be compared with Mixed-effects model repeated measures (MMRM), where the baseline is scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline will be statistically described.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neuroendocrine TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Baoxia He, Study director, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963193
- Sponsor's protocol ID
- HNCH-GI-005
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Etoposide Plus Cisplatin Compared With Irinotecan Plus Cisplatin for First-line Treatment of Non-primary Pancreatic Metastatic and/or Unresectable Gastrointestinal Neuroendocrine Tumor G3 Type
- ClinicalTrials.gov ID
- NCT03963193
- Acronym / sponsor ID
- HNCH-GI-005
- Conditions
- Gastrointestinal Neuroendocrine Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 24 May 2019 (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.
The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
Detailed description
The prognosis of gastrointestinal neuroendocrine tumor G3 type patients who cannot be surgically resected is poor. The median overall survival (OS) is only 6-10 months, and the 3-year survival rate is less than 10%. Among the neuroendocrine tumors of the digestive system, only pancreatic neuroendocrine tumor has a standard treatment strategy, and there is a lack of prospective clinical research data on other gastrointestinal neuroendocrine tumors. According to the chemotherapy regimen of small cell lung cancer, etoposide plus cisplatin or irinotecan plus cisplatin is the choice of rescue therapy for advanced non-surgical or metastatic neuroendocrine tumor G3 type. However, prospective studies are needed to confirm whether there are differences in efficacy and safety between the two chemotherapy regimens. The aim of this study is to investigate the efficacy, safety, and survival benefit of etoposide plus cisplatin and irinotecan plus cisplatin in first-line therapy of non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type. In addition, the investigators will explore the resistance mechanisms of gastrointestinal neuroendocrine tumor G3, and screen out biomarkers that can predict the efficacy of chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Etoposide plus Cisplatin | Experimental | Drug: EtoposideEtoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over. |
| Irinotecan plus Cisplatin | Experimental | Drug: IrinotecanIrinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days. When the investigator believes that the participant is not suitable for continued medication or the evaluation is progressive disease (PD) according to the RECIST 1.1 standard, the medication is over. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1. 18-75 years old, male or female. 2. Confirmed non-primary pancreatic metastatic and/or unresectable gastrointestinal neuroendocrine tumor G3 type patients by histopathological and imaging examinations.
- 3. ECOG performance status 0-1. 4. Life expectancy ≥ 12 weeks. 5. A histological specimen can be provided for secondary testing. 6. According to the evaluation criteria of solid tumor efficacy (RESIST 1.1), there should be at least one measurable lesion (empty organs such as esophagus and stomach cannot be taken as the measurable lesion), and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area is also selected as the target lesion if the lesion progression is confirmed).
- 7. Never received system treatment before, including cytotoxic drugs. For patients who have received adjuvant or neoadjuvant chemotherapy appears recurrence or metastasis more than 6 months from accepting the last dose of chemotherapy drugs can be screened.
- 9. Fertile men and women must use effective contraception during the study period and within 6 months after the end of the study.
- 10. Volunteered to participate in the study and signed an informed consent form.
Key exclusion criteria (23 listed)
- 1.Patients exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in site, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor infiltrating basement membrane)); Patients with rapid progress within 3 months.
- 2. History of gastrointestinal perforation and/or fistula within 6 months prior to the first administration.
- 3. Patients who had received radiotherapy for tumor target lesions within 4 weeks before enrollment.
- 4. History of immunodeficiency disease, including HIV positive and other acquired or congenital immunodeficiency diseases.
- 6. Significantly malnourished patients. Exclusion is performed if the patient is receiving intravenous fluids or is required to be hospitalized for continuous infusion therapy. Patients with good nutrition control ≥ 28 days can be enrolled before randomization.
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 |
|---|---|---|
| EtoposideAlso: CisplatinEtoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days. | Drug | Etoposide plus Cisplatin |
| IrinotecanAlso: CisplatinIrinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days. | Drug | Irinotecan plus Cisplatin |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
To compare objective response rate of the two arms from date of anti-cancer therapy until progression
Progression-free Survival (PFS)
Time frame: up to 2 years
From the first day of treatment until the date of first documented progression or date of death from any cause
3 secondary outcomes
Overall survival (OS)
Time frame: up to 2 years
Number of Participants with Treatment-related Adverse Events
Time frame: up to 2 years
Assessment of Health-related quality of life
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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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. This study is not recruiting at the moment.
Baoxia He study director
Henan Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Etoposide and Irinotecan in people with Gastrointestinal Neuroendocrine Tumor, run by Henan Cancer Hospital.
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 9 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 24 May 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Liu (13783604602, yaya7207@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 24 May 2019.