Clinical Significance of Circulating Tumor Cells (CTCs) in Blood of Patients With Advanced/Metastatic Gastric Cancer
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Beijing
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Beijing, Beijing, Kina, 100142
- Department of GI Oncology, Peking University Cancer Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: cisplatin plus capecitabine
gastric cancer patients treated with capecitabine/cisplatin
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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. |
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Experimentell: capecitabine plus paclitaxel
gastric cancer patients treated with capecitabine/paclitaxel
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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circulating tumor cells in blood
Tidsram: every 6 weeks
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every 6 weeks
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CGOG5001
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