Study of Bevacizumab Plus Chemotherapy in Patients With Metastatic Colorectal Cancer

NCT ID: NCT01679327

Last Updated: 2012-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the relationship of biomarker expression and efficacy of bevacizumab plus chemotherapy in patients with unresectable/metastatic colorectal cancer. Before the treatment, the investigators detect the VEGF-A,VEGF-C,VEGF-D,VEGFR-1,VEGFR-2,VEGFR-3 expression in tumor tissue by IHC and detect those protein expression level in plasma by ELISA. After at least 6 weeks treatment, the investigators detect again VEGF-A,VEGF-C,VEGF-D expression level in plasma by ELISA. The aim of the study is to identify whether those biomarkers could predict Bevacizumab efficacy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Bevacizumab plus chemotherapy(XELOX or FOLFOX)

Bevacizumab plus XELOX (Bevacizumab 7.5mg/kg d1;Xeloda 2g/m2 d1-14 divided into two times;Oxaliplatin 130mg/m2 d1;repeated in 21 days) Bevacizumab plus FOLFOX (Oxaliplatin 85mg/ m2 ivgtt d1;CF 200mg/ m2 ivgtt d1;Bevacizumab 5mg/kg ivgtt d1 5-FU 400mg /m2 ivgtt d1;5-FU 2400mg/m2 CIV 48h;repeated in 14 days)

Group Type EXPERIMENTAL

Oxaliplatin

Intervention Type DRUG

Xeloda

Intervention Type DRUG

Calcium folinate (CF)

Intervention Type DRUG

5-FU

Intervention Type DRUG

Bevacizumab

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oxaliplatin

Intervention Type DRUG

Xeloda

Intervention Type DRUG

Calcium folinate (CF)

Intervention Type DRUG

5-FU

Intervention Type DRUG

Bevacizumab

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Eloxatin Capetabine Calcium folinate Avastin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

yihebali chi

associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yihebali Chi, Doctor

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences

Jinwan WANG

Role: STUDY_DIRECTOR

Chinese Academy of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cancer Institute&Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yihebali Chi, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WY0524

Identifier Type: -

Identifier Source: org_study_id