a Prospective Study on the Efficacy and Safety Using Sequential Therapy of Irinotecan Combined With Cisplatin (IP)and Octretide Lar in the First Line Treatment of Metastatic or Inoperable Gastrointestinal Poorly Differentiated Neuroendocrine Carcinoma: the IPO-NEC Trial
- Written Informed consent
- Male or female patients >=18 years old
- Histologically or cytologically confirmed poorly differentiated neuroendocrine
carcinoma originating from the GI tract. The grade of the disease is grade 2 or grade
- No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy
or others. In case the patient received adjuvant therapy after surgery, enrollment is
allowed if the adjuvant therapy doesn't contain cisplatin or irinotican and at the
same time, the last day of chemotherapy is ≥180 days before screening.
- Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before
- The laboratory parameter meets the following criteria 7 days before enrollment
- Hemoglobin ≥90g/L
- Absolute neutrophil count≥1.5×10^9/L, platelets 100×10^9/L；
- ALT and AST≤2.5 ULN(in case of the patients with liver metastasis,ALT and AST≤5.0
- ALP ≤2.5 ULN (in case of the patients with liver metastasis,≤5.0 ULN)
- Total Serum bilirubin ≤1.5 ULN
- Serum creatinine ≤1.0 ULN
- KPS ≥70
- Estimated survival ≥90 days
- Women of childbearing potential must have a negative serum or urine pregnancy test
within 7 days of enrollment and must be willing to use adequate methods of
contraception during the study and for 30 days after last study durg administration.
- Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment
agents including irinotecan, cisplatin and octreotide lar
- Any participation in trials simultaneously or 4 weeks before screening.
- Undergone major surgery ≤ 4 weeks prior to starting study drug or who have not
recovered from side effects of such surgery.
- Uncontrolled severe diarrhea
- Unconrolled active infection (fever ≥38 degrees due to infection)
- severe hepatopathy including active hepatitis and hepatic cirrhosis, renal
dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary
fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and
other chronic systematic diseases.
- Chronic treatment with steroids.(In case of the patients with short-term use of
steroids, the enrollment is permitted if the administration is stopped 2 weeks before
- confirmed or suspected CNS metastasis
- the history of peripheral nervous system impairment, obvious mental disorder or CNS
- clinically significant heart disease, including congestive heart failure, symptomatic
coronal heart disease, arrythmia uncontrolled by medication and acute myocardial
infarction or cardiac insufficiency within 6 months before screening
- pregnant women or women in lactation period
- Fertile male or women of child-bearing potential refuse to take highly effective
methods of birth control
- Incidence of other second primary malignant tumors, except for cured basal cell
carcinoma and cervical carcinoma in situ.
- patients of legal incapacity or who have the potential of influence the whole trial
due to medical or ethic reasons.
- Other patients who are not eligible to the trial under investigators' discretion