Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
no-prior chemotherapy
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Intervention
Name: CellSearch® CTC kit
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Department of GI Oncology, Peking University Cancer Hospital
Beijing, Beijing, China
Status: Recruiting
Contact: Jifang Gong, MD - 861088196561 - gongjifang@gmail.com
Start Date
June 2012
Completion Date
December 2015
Sponsors
Peking University
Source
Peking University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page