- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963193
Etoposide/Cisplatin Compared With Irinotecan/Cisplatin for Advanced Gastrointestinal Neuroendocrine Tumor G3 Type
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ying Liu
- Phone Number: 13783604602
- Email: yaya7207@126.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- 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.
Exclusion Criteria:
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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Etoposide plus 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.
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.
|
Etoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days.
Other Names:
|
Experimental: Irinotecan plus 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.
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 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 2 years
|
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
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Health-related quality of life
Time Frame: up to 2 years
|
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.
|
up to 2 years
|
Overall survival (OS)
Time Frame: up to 2 years
|
From the first day of treatment to death or last survival confirm date
|
up to 2 years
|
Number of Participants with Treatment-related Adverse Events
Time Frame: up to 2 years
|
Treatment-related adverse events will be assessed by CT CAE v4.0
|
up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Baoxia He, Henan Cancer Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Intestinal Diseases
- Pancreatic Diseases
- Stomach Neoplasms
- Pancreatic Neoplasms
- Neuroendocrine Tumors
- Intestinal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Etoposide
- Cisplatin
- Irinotecan
Other Study ID Numbers
- HNCH-GI-005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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