Screening for genetic markers in advanced HER2 positive gastric cancer
Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy
This study is trying to find genetic markers in the blood of patients with advanced HER2 positive gastric cancer to see how they relate to the effectiveness of a specific treatment called trastuzumab.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ruijin Hospital Academic / other |
| Drugs / interventions | trastuzumab, chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04520295 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify a molecular biomarker panel that correlates with the efficacy of trastuzumab in patients with advanced HER2 positive gastric cancer. It utilizes next-generation sequencing to detect molecular events such as gene mutations, fusions, and amplifications in circulating tumor DNA (ctDNA) collected from blood samples. Samples will be collected from HER2 positive patients at baseline, after initial treatment, and upon disease progression, while HER2 negative patients will serve as a control group. The study focuses on understanding the molecular evolution of HER2 positive gastric cancer during treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed advanced HER2 positive gastric adenocarcinoma who are treatment naïve or have recurrent disease.
Not a fit: Patients with HER2 negative gastric cancer or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for patients with advanced HER2 positive gastric cancer.
How similar studies have performed: Other studies have shown promise in using ctDNA for monitoring treatment response in various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Department of Oncology, Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jun Zhang — Ruijin Hospital
- Study coordinator: Jing Liu
- Email: liujing23@vip.163.com
- Phone: +86-18001753364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.