ctDNA Screening in Advanced HER2 Positive Gastric Cancer

HER2-positive Gastric Cancer Clinical Trial

Official title:

Predictive Biomarkers Screening by ctDNA Detection in Advanced HER2 Positive Gastric Cancer Patients Treated by Trastuzumab Plus Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520295
• Other study ID #: BSctDNA-GC
• Status: Recruiting
• Start date: May 19, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: August 2020
• Source: Ruijin Hospital
• Contact: Jing Liu
• Phone: +86-18001753364
• Email: liujing23[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 during treatment by ctDNA detection.

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 of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HER2-positive Gastric Cancer
• Stomach Neoplasms

Intervention

Genetic:
• ctDNA screening
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 of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.

Locations

Country	Name	City	State
China	Department of Oncology, Ruijin Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in molecular biomarkers at time on best overall response	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.	36 months
Secondary	Change from baseline in molecular biomarkers at time on disease progression	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.	36 months