Brief Summary

Dynamic multiomics explore the efficacy and mechanism of anti-HER2 \& immunotherapy of HER2 Positive GC

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 years study duration

Study Start

First participant enrolled

January 1, 2019

Completed

3.1 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2022

Completed

3 months until next milestone

First Posted

Study publicly available on registry

April 27, 2022

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed

2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed

Last Updated

April 27, 2022

Status Verified

December 1, 2021

Enrollment Period

4 years

First QC Date

January 29, 2022

Last Update Submit

April 20, 2022

Conditions

HER2 Positive Advanced Gastric Cancer

Outcome Measures

Primary Outcomes (5)

Proportions of HER2 & PD-L1 positive CTC
Numbers of CTC and proportions of HER2 or PD-L1 positive CTC collected at treatment baseline and every time point response will be calculated and recorded. Proportions of HER2 and PD-L1 positive CTC will be compared between two groups.
2 months
Incidence rate of ctDNA deletion, amplification, insertion and other types of variation evaluated by next generation sequence(NGS).
NGS will be proceeded to detect the ctDNA variations features at treatment baseline and every time point response will be recorded and compared between two groups.
2 months
Proportions of lymphocytes, stromal cells, tumor cells in tumor tissue assessed by single cell transcriptome sequence.
single cell digested from tumor tissue will be administrated to 10× genomics single cell transcriptome sequence. Proportions of lymphocytes, stromal cells, tumor cells assessed by single cell transcriptome sequence at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.
Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Incidence rate of gene deletion, amplification, insertion and other types of variation of tumor evaluated by whole exon sequence(WES).
DNA extracted from tumor tissue will be administrated to whole exon sequence.Variation features at treatment baseline, the second time point response and disease progression time point will be recorded and compared between two groups.
Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Tumor associated proteins expression level of tumor
96 tumor associated proteins' expression level of tumor at treatment baseline, second time point response and disease progression time point will be recorded and compared between two groups.
Treatment baseline; Up to 2 months from the initial treatment; From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (2)

Anti-HER2 & Immunotherapy

OTHER

Advancd gastric cancer patients received anti-HER2 \& immunotherapy ± chemotherapy

Procedure: Samples including blood and tissue collectionProcedure: CTC detectionProcedure: ctDNA detectionProcedure: 10×genomics single cell RNA sequenceProcedure: Whole exon sequenceProcedure: Proteomics detection

Anti-HER2

OTHER

Advancd gastric cancer patients received anti-HER2 ± chemotherapy.

Interventions

Samples including blood and tissue collectionPROCEDURE

Tissue and peripheral blood sample of 100 gastric cancer patients will be collected at the baseline and time point response of therapy.