Clinical trial · Observational
ctDNA Screening in Advanced HER2 Positive Gastric Cancer
Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy
NCT04520295CI-TRIAL-00046734unknownClinicalTrials.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 molecular biomarker panel correlating with efficacy of trastuzuamb in advanced HER2 positive gastric cancer patients. To observe the molecular evolution of HER2 positive gastric cancer during treatment by ctDNA detection.
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 Gastric Cancer | HER2-Positive Gastric Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA screening | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2 positive cohort
- interventionNames
- Genetic: ctDNA screening
Primary outcomes (1)
- measure
- Change from baseline in molecular biomarkers at time on best overall response
- timeFrame
- 36 months
- description
- Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file.
Secondary outcomes (1)
- measure
- Change from baseline in molecular biomarkers at time on disease progression
- timeFrame
- 36 months
- description
- Molecular biomarkers including gene mutation, amplification and fusion were detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from patients during treatment. The list of genes included in OncoScreen Plus panelTM is provided as supplementary file.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male/female patients aged over 18 years. 2. Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy. 3. HER2 status is confirmed by IHC/FISH. HER2 positive: IHC 3+ or IHC 2+ plus FISH positive, HER2 negative: IHC 0/1+ or IHC 2+ plus FISH negative. 4. At least one measurable lesion should be confirmed by imaging examination. 5. Eligible peripheral blood samples 6. Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy. 7. For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil. 8. For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients. 9. Willing to provide clinicopathological information and imaging information. Exclusion Criteria: 1. Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months. 2. With second primary malignant diseases. 3. Other situations assessed by investigator can disturb quality control of the investigation.
References
Publications (0)
Data not yet available
No reference posted for this study.