Deciphering the Molecular Traits of Non-canonical Responders to Advance Personalized Therapy in Gastric Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06877910

Enrollment

220

Registered

2025-03-14

Start date

2021-01-10

Completion date

2026-01-10

Last updated

2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Gastric Cancer

Brief summary

Retrospective-prospective observational study in which a novel whole-exome sequencing (WES) approach will be used in association with whole-transcriptome sequencing (WTS) to analyze two independent and equally sized cohorts of patients with mGC.

Detailed description

A workflow specifically designed for this project will be adopted, using clinical outcomes as a benchmark for comparative analyses, to generate a molecular classifier applicable to all patients affected by metastatic gastric cancer mGC and predict atypical tumor responses. Molecular features differently represented in exceptional responders and fast progressors will be monitored by liquid biopsy in patients included in cohort B, consisting of a validation set, leveraging a high-sensitivity technological level that allows to detect both genomic alterations and expression at the transcription level. In addition, CSCs isolated from fast progressors will be studied with over 1,000 antitumor agents to discover vulnerabilities not currently known.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \>18 years; * Histological diagnosis of locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction carcinoma (EJC); * Adequate biological material for molecular analysis, collected (at surgery or by biopsy) before the administration of any anti-tumor treatment (chemotherapy and/or radiotherapy); * ECOG PS 0-2; * Adequate hematological, hepatic and renal function; * Measurable disease according to RECIST criteria; * Written informed consent.

Exclusion criteria

* Previous chemotherapy for metastatic disease; * Comorbidities not controlled with adequate medical therapy; * Brain metastases; * Patient unable to give adequate consent to the study.

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival PFS	5 years	PFS will be defined as the time from the start of first-line chemotherapy to disease progression or death

Secondary

Measure	Time frame	Description
Overall survival OS	5 years	OS will be defined as the time from the start of first-line chemotherapy to death (from any cause)

Countries

Italy

Outcome results