Overview

Etoposide/Cisplatin Compared With Irinotecan/Cisplatin for Advanced Gastrointestinal Neuroendocrine Tumor G3 Type

Status:
Unknown status
Trial end date:
2021-06-01
Target enrollment:
0
Participant gender:
All
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. 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Henan Cancer Hospital
Treatments:
Cisplatin
Etoposide
Etoposide phosphate
Irinotecan
Criteria
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:

1. 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.

2. 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.

3. 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:

1. A history of allergy to the ingredients of the study drug;

2. 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:

1. Patients with hypertension whose blood can't be well controlled by
antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood
pressure ≥ 100 mmHg).

2. 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.

3. 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.

4. Renal failure requiring hemodialysis or peritoneal dialysis.

5. Patients of diabetes who have poor glycemic control (fasting blood glucose (FBG)
> 10 mmol/L).

6. 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.