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

Sponsor
Henan Cancer Hospital
Study ID
NCT03963193
Phase
PHASE2
Status
Unknown

Conditions

  • Gastrointestinal Neuroendocrine Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Etoposide — DRUG
    Etoposide 100mg/m\^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m\^2 ivggt on days 1, 2, 3, repeated every 21 days.
  • Irinotecan — DRUG
    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 Details

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.

Key Dates

Start date
Jun 1, 2019
Status verified
May 2019
Primary completion
Jun 1, 2020
Completion
Jun 1, 2021

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: up to 2 years ]

Central Contacts

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