Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab in Pancreatic Cancer Patients

Sponsor
Herlev Hospital
Study ID
NCT02767557
Phase
PHASE2
Status
Completed

Conditions

  • Unresectable Pancreatic Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    Intravenous infusion
  • Gemcitabine — DRUG
    Intravenous infusion
  • nab-Paclitaxel — DRUG
    Intravenous infusion,

Study Details

This is a multicenter center, 2-arms prospective randomized phase II trial which evaluates whether tocilizumab with gemcitabine/nab-paclitaxel is more effective than gemcitabine/nab-paclitaxel.

Key Dates

Start date
Jan 26, 2017
Status verified
Sep 2023
Primary completion
Aug 12, 2021
Completion
Jan 1, 2023

Study Design

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

Arms

  • Experimental: Tocilizumab & Gemcitabine and nab-Paclitaxel
    Tocilizumab: 8 mg/kg given I. V. on day 1 over 60 minutes every 28 day cycle. Gemcitabine: 1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Nab-Paclitaxel: 125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle.
  • Active Comparator: Gemcitabine and nab-Paclitaxel
    Gemcitabine: 1000 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle. Nab-Paclitaxel: 125 mg/m² I. V. on day 1, day 8 and day 15 of every 28 day cycle.

Primary Outcome Measure

Overall survival at 6 months [ Time Frame: Approximately up to 6 months. ]

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