ctDNA Screening in Advanced HER2 Positive Gastric Cancer

Shanghai Jiao Tong University

Status: Enrolling

Conditions: HER2-positive Gastric Cancer

Treatments: Genetic: ctDNA screening

Study type: Observational

Funder types: Other

Identifiers

NCT04520295

BSctDNA-GC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

HER2 positive cohort

Treatment:

Genetic: ctDNA screening