Clinical trial · Interventional
HER2 Positive CTC in Advanced Gastric Cancer
Clinical Significance of HER2 Positive Circulating Tumor Cells(CTCs) in the Peripheral Blood of Patients With Advanced Gastric Cancer
NCT01847794CI-TRIAL-00010225AGC-HER2CTCunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To identify the correlation of HER2 expression in tissue and peripheral CTC. to identify the HER2 expression in CTCs with clinical prognosis in advanced/metastatic gastric cancer. Confirm the presence of CTCs are sensitive for monitoring response to chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Positive Advanced Gastric Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cell Search® CTC epithelial kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemotheropy
- interventionNames
- Device: Cell Search® CTC epithelial kit
Primary outcomes (1)
- measure
- HER2 positive CTC
- timeFrame
- 2 months
Secondary outcomes (1)
- measure
- clinical significance of HER 2 positive CTC
- timeFrame
- 2years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Having signed informed consent * Age≥ 18 years old * HER2 overexpression confirmed by IHC or ISH (IHC 3+,or IHC2+/ISH+) * Histologically confirmed gastric adenocarcinoma * Unresectable recurrent or metastatic disease * Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months * Measurable disease according to the RECIST criteria * Karnofsky performance status ≥70 * Life expectancy of ≥3 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: * Previous systemic therapy for metastatic gastric cancer * 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 * Other previous malignancy within 5 year, except non-melanoma skin cancer * Legal incapacity
References
Publications (0)
Data not yet available
No reference posted for this study.