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

Summary

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 and XELIRI alternation regimen in the first-line treatment of advanced colorectal cancer.

Conditions

• Colorectal Neoplasms
• Chemotherapy

Interventions

DRUG

XELIRI

Irinotecan，200mg/㎡,d1;Capecitabine, 850-1250mg/㎡ bid 1-14;every 21 days as a cycle

DRUG

XELOX

Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid 1-14;every 21 days as a cycle

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• Fudan University

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Jilin Provincial Tumor Hospital

  collaborator OTHER

• Jinzhou Medical University

  collaborator OTHER

• Harbin Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-03-01

Primary Completion

2019-12-01

Completion

2020-06-01

Countries

• China

Study Locations