XELOX+Bevacizumab and XELIRI + Bevacizumab Alternative Regimen as First-line Treatment for Advanced Colorectal Cancer

Sponsor
Harbin Medical University
Study ID
NCT03511183
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • XELIRI + bevacizumab — DRUG
    Irinotecan，200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle
  • XELOX + bevacizumab — DRUG
    Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle

Study Details

Colorectal cancer will be resistant to Chemotherapy drugs after treated for a period of time .In the past, the classical treatment regiment was to change other drug after tumor progressed. In theory, the continuous use of such a drug could shortening the patient's drug resistance time. It has been shown that the alternate use of the two drug combinations is reasonable in clinical. This application can not only further improve the curative effect but also significantly reduce the side effects. So the investigators are going to carry out a prospective phase II clinical study. The control group change to second-line treatment after progression of first-line drugs. The experimental group use the first line and the second line,alternately, for every two cycles. The combination of bevacizumab is a first line development, and the second line can still be used . Objective to compare the clinical value of XELOX + bevacizumab and XELIRI + bevacizumab alternation regimen in the first-line treatment of advanced colorectal cancer.

Key Dates

First listed
Apr 27, 2018
Start date
Mar 1, 2018
Status verified
Apr 2018
Primary completion
Dec 1, 2019
Completion
Jun 1, 2020

Study Design

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

Arms

  • Experimental: alternative regiment
    The first stage:XELOX + bevacizumab chemotherapy and XELIRI + bevacizumab chemotherapy (alternation of every two cycles) until one of the schemes appears imaging progress or intolerance.And then enter the second stage. The second stage: continue to apply another plan until there is progress or intolerance.
  • Placebo Comparator: classical regiment
    Use the XELOX + bevacizumab chemotherapy until appears imaging progress or intolerance.And then change to the XELIRI + bevacizumab chemotherapy until there is progress or intolerance.

Primary Outcome Measure

Adverse Events [ Time Frame: 22 months ]

Central Contacts

Related Studies