Clinical trial · Observational
Liquid Biopsy in Monitoring the Therapeutic Efficacy of Targeted Therapy in Advanced/Metastatic Gastric Cancer
NCT02610218CI-TRIAL-00030127unknownClinicalTrials.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 evaluate the clinical significance of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in real-time monitoring the therapeutic response during HER2-targeted therapy in histologically confirmed HER2 positive advanced/metastatic gastric cancer.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CTC and cfDNA analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- histo-HER2+ gastric cancer patients
- description
- Histologically HER2 positive gastric cancer patients treated with HER2 targeted therapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease.
- interventionNames
- Other: CTC and cfDNA analysis
- label
- histo-HER2- gastric cancer patients
- description
- Histologically HER2 negative gastric cancer patients treated with chemotherapy. Interventions: peripheral blood samples of 12.5 mL for CTC and cfDNA analysis will be collected before targeted therapy, at the time that they achieve the optimal response and when they suffer progressive disease.
- interventionNames
- Other: CTC and cfDNA analysis
Primary outcomes (1)
- measure
- Correlation of HER2 status on CTCs and cfDNA with clinical outcomes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Having signed informed consent * Age≥ 18 years old * Histologically confirmed HER2 positive gastric adenocarcinoma * Unresectable recurrent or metastatic disease * Measurable disease according to the RECIST criteria * Karnofsky performance status ≥60 * Life expectancy of ≥2 month * 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) * 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 * Pre-existing neuropathy\>grade 1 * Legal incapacity
References
Publications (0)
Data not yet available
No reference posted for this study.