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Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CellSearch® CTC kit

About this trial

This is an interventional basic science trial for Gastric Cancer focused on measuring no-prior chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Having signed informed consent
Age≥ 18 years old
Histologically confirmed gastric adenocarcinoma
Unresectable recurrent or metastatic disease
Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months
Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months.
Measurable disease according to the RECIST criteria
Karnofsky performance status ≥60
Life expectancy of ≥2 month
No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)
Serum albumin level ≥3.0g/dL
Serum AKP < 2.5 times ULN
Serum creatinine <ULN, and CCr < 60ml/min
Bilirubin level < 1.5 ULN
WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

Brain metastasis (known or suspected)
Previous systemic therapy for metastatic gastric cancer
Inability to take oral medication
Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy
Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on.
Allergic constitution or allergic history to protium biologic product or any investigating agents.
Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension.
Pregnancy or lactation period
Any investigational agent within the past 28 days
Other previous malignancy within 5 year, except non-melanoma skin cancer
Previous adjuvant therapy with capecitabine+platinum,
Pre-existing neuropathy>grade 1
Legal incapacity

Sites / Locations

Department of GI Oncology, Peking University Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

cisplatin plus capecitabine

capecitabine plus paclitaxel

Arm Description

gastric cancer patients treated with capecitabine/cisplatin

gastric cancer patients treated with capecitabine/paclitaxel

Outcomes

Primary Outcome Measures

circulating tumor cells in blood

Secondary Outcome Measures

Full Information

NCT ID

NCT01625702

First Posted

June 13, 2012

Last Updated

May 7, 2017

Sponsor

Peking University

1. Study Identification

Unique Protocol Identification Number

NCT01625702

Brief Title

Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University

4. Oversight

5. Study Description

Brief Summary

To identify the correlation of CTCs with clinical prognosis in advanced/metastatic gastric cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

no-prior chemotherapy

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cisplatin plus capecitabine

Arm Type

Experimental

Arm Description

gastric cancer patients treated with capecitabine/cisplatin

Arm Title

capecitabine plus paclitaxel

Arm Type

Experimental

Arm Description

gastric cancer patients treated with capecitabine/paclitaxel

Intervention Type

Device

Intervention Name(s)

CellSearch® CTC kit

Intervention Description

Collect peripheral blood sample of 100 gastric cancer patients pre-chemotherapy treated with capecitabine/paclitaxel (XPa) and capecitabine/cisplatin (XP) and post two cycles of chemotherapy(response evaluation). Blood samples will be transferred to central lab to detect CTCs by Cellsearch kit. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.

Primary Outcome Measure Information:

Title

circulating tumor cells in blood

Time Frame

every 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Having signed informed consent Age≥ 18 years old Histologically confirmed gastric adenocarcinoma Unresectable recurrent or metastatic disease Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12 months. Measurable disease according to the RECIST criteria Karnofsky performance status ≥60 Life expectancy of ≥2 month No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases) Serum albumin level ≥3.0g/dL Serum AKP < 2.5 times ULN Serum creatinine <ULN, and CCr < 60ml/min Bilirubin level < 1.5 ULN WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl Exclusion Criteria: Brain metastasis (known or suspected) Previous systemic therapy for metastatic gastric cancer Inability to take oral medication Previous therapy targeting at angiogenesis or vasculogenesis pathway or other targeted therapy Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry Contraindications of nuclear magnetic resonance image such as fitment of cardiac pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye ball and so on. Allergic constitution or allergic history to protium biologic product or any investigating agents. Severe heart disease or such history as recorded congestive heart failure, uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve disease, severe abnormal ECG findings, cardiac infarction , or retractable hypertension. Pregnancy or lactation period Any investigational agent within the past 28 days Other previous malignancy within 5 year, except non-melanoma skin cancer Previous adjuvant therapy with capecitabine+platinum, Pre-existing neuropathy>grade 1 Legal incapacity

Facility Information:

Facility Name

Department of GI Oncology, Peking University Cancer Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100142

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

29178102

Citation

Li Y, Peng Z, Zhang X, Gong J, Shen L. [Value of serum human epithelial growth factor receptor 2 extracellular domain and circulating tumor cells in evaluating therapeutic response in advanced gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2017 Nov 25;20(11):1293-1299. Chinese.

Results Reference

derived

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Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer

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