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

Peking University

Status: Completed

Conditions: Gastric Cancer

Treatments: Device: CellSearch® CTC kit

Study type: Interventional

Funder types: Other

Identifiers

NCT01625702

CGOG5001

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

cisplatin plus capecitabine

Experimental group

Description:

gastric cancer patients treated with capecitabine/cisplatin

Treatment:

Device: CellSearch® CTC kit

capecitabine plus paclitaxel

Experimental group

Description:

gastric cancer patients treated with capecitabine/paclitaxel

Treatment:

Device: CellSearch® CTC kit