Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer

Sponsor
Zhejiang University
Study ID
NCT02558868
Phase
PHASE2
Status
Completed

Conditions

  • Pancreatic Neoplasms

Eligibility Criteria

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

Interventions

Study Details

This study is a randomized, open-label, controlled study that will compare the efficacy of oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for patients with gemcitabine and S-1 refractory pancreatic cancer.

Key Dates

Start date
Sep 1, 2015
Status verified
Jun 2018
Primary completion
Sep 30, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oxaliplatin + Irinotecan
    Irinotecan：160 mg/m2，iv 120 min，d1 q2w oxaliplatin: 85 mg/m2，iv 120 min，d1 q2w
  • Active Comparator: Irinotecan
    Irinotecan：180 mg/m2，iv 120 min，d1 q2w

Primary Outcome Measure

Overall Survival [ Time Frame: 1 years ]

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