Study of M2ES With Paclitaxel/Carboplatin (TC Regimen) in Advanced Non Small Cell Lung Cancer (NSCLC)

NCT ID: NCT01099124

Last Updated: 2013-01-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to evaluate safety and tolerance of M2ES with TC regimen in advanced NSCLC.

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M2ES combined with chemotherapy

Group Type EXPERIMENTAL

M2ES

Intervention Type DRUG

polyethylene glycol rh recombinant endostatin

Interventions

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M2ES

polyethylene glycol rh recombinant endostatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Aged 18-70 years old;
2. Patients with Ⅲ/Ⅳ NSCLC confirmed by histopathology or cytology who ware naive or previous chemotherapy without TC regimen;
3. No contraindication for chemotherapy;
4. ECOG performance scale 0-2;
5. No history of anti-angiogenesis therapy;
6. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria

1. Concurrent use of other anti-cancer agents;
2. Allergic history to M2ES and biological agents;
3. Pregnant or breast-feeding women;
4. With other malignancy;
5. With severe cardiopulmonary disease;
6. Uncontrolled brain metastasis patients;
7. Other conditions that are regarded for exclusion by the trialists.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kai LI

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institude and Hospital

Locations

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Tianjin Medical University Cancer Institude and Hospital

Tianjin, , China

Site Status

Countries

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China

Other Identifiers

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TMU-CIH-CTI-001

Identifier Type: -

Identifier Source: org_study_id

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