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Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer


Inclusion Criteria:



- More than 18-years old,male or female

- Pathologically approved as unresectable/metastatic colorectal cancer

- KPS > 70% or ECOG 0-2

- HGB > 80 g/L, NEUT ≥ 1.5x109 /L, PLT ≥ 80x109 /L; CR < 1.5 x Upper normality，

- TB < 1.5 X Upper normality，AST or ALT < 2.5 x Upper normality.

- Signed consent

Exclusion Criteria:

- Other malignancies simultaneously except in situ cervix or nonmelanoma skin cancer

- Pregnancy or in lactation

- HGB < 80 g/L, NEUT < 1.5x109 /L, PLT < 80x109 /L; CR ≥ 1.5 x Upper normality， TB ≥
2.5 X Upper normality，AST or ALT ≥2.5 x Upper normality，AKP ≥ 2.5 X Upper normality

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Description:

During the chemotherapy,all the patients demonstrate CT scan or MR to evaluate tumor response to therapy every two cycles.According to RECIST 1.1,tumor response was recorded.

Outcome Time Frame:

36 months

Safety Issue:

No

Principal Investigator

Yihebali Chi, Doctor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chinese academy of medical science

Authority:

China: Food and Drug Administration

Study ID:

WY0524

NCT ID:

NCT01679327

Start Date:

March 2012

Completion Date:

September 2014

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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