Efficacy and Safety of Bevacizumab Plus Sorafenib for the Third-line Treatment in Metastatic Renal Cancer Patients

Sponsor
Peking University Cancer Hospital & Institute
Study ID
NCT02330783
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Bevacizumab — DRUG
    5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
  • Sorafenib — DRUG
    400mg twice daily by oral of each 4-week cycle

Study Details

There is no standard treatment in patients with renal cell carcinoma that was previously treated with VEGF targeted therapies and mTOR inhibitors.So investigators conducted a randomized, open-label, multi-center phase II study to compare bevacizumab plus sorafenib versus sorafenib for the third-line treatment of patients with Metastatic renal cell carcinoma.

Key Dates

First listed
Jan 5, 2015
Start date
Dec 31, 2014
Status verified
May 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018

Study Design

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

Arms

  • Experimental: Bevacizumab plus Sorafenib
    Bevacizumab 5mg/kg Q2w Sorafenib 400mg Bid
  • Active Comparator: Sorafenib
    Sorafenib 400mg Bid

Primary Outcome Measure

progress-free survival,PFS [ Time Frame: 2 years ]

Central Contacts

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