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

Active, not recruiting

• Conditions: Metastatic Gastric Cancer

• Registration Number: NCT06877910
• Lead Sponsor: Regina Elena Cancer Institute

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.

Study Timeline

• Study Start: 2021-01-10
• Primary Completion: 2023-06-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-10
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

IRCCS National Cancer institute; 🇮🇹 Rome, Italy