Status:
UNKNOWN
ctDNA Screening in Advanced HER2 Positive Gastric Cancer
Lead Sponsor:
Ruijin Hospital
Conditions:
HER2-positive Gastric Cancer
Eligibility:
All Genders
18+ years
Brief Summary
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 dur...
Detailed Description
Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples...
Eligibility Criteria
Inclusion
- Male/female patients aged over 18 years.
- Histologically confirmed gastric adenocarcinoma. Gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy.
- 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.
- At least one measurable lesion should be confirmed by imaging examination.
- Eligible peripheral blood samples
- Patients with enough organ function and performance status (ECOG 0-2) can tolerant chemotherapy.
- For HER2 positive patients, trastuzumab should be used as first-line treatment. The regimen of chemotherapy should be platinum plus oral fluorouracil.
- For HER2 negative patients, clinicopathological characteristics should be matched to HER2 positive patients.
- Willing to provide clinicopathological information and imaging information.
Exclusion
- Patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months.
- With second primary malignant diseases.
- Other situations assessed by investigator can disturb quality control of the investigation.
Key Trial Info
Start Date :
May 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04520295
Start Date
May 19 2020
End Date
May 31 2025
Last Update
August 20 2020
Active Locations (1)
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1
Department of Oncology, Ruijin Hospital
Shanghai, China, 200025