Analyzing factors for predicting chemotherapy response in gastric cancer
Official title: InteGRAtive Analysis of TuMor, Microenvironment, ImmunitY and Patient Expectation for Personalized Response Prediction in Gastric Cancer
Run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · NCT04842916 · Data updated 2026-11-12
This study is trying to find out which factors can help predict how well patients with gastric cancer will respond to chemotherapy, so that doctors can better tailor treatments for them.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Brest and 4 other locations) |
| Status | Recruiting |
| Started | September 22, 2020 |
| Main results expected | May 22, 2027 |
| Study ends | May 22, 2027 |
| Registry record updated | November 21, 2024 |
| Trial ID | NCT04842916 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with histologically confirmed, potentially resectable gastric adenocarcinoma or gastric-esophageal junction cancer who are undergoing standard chemotherapy regimens.
✕Probably not a fit
Patients with early-stage gastric cancer, distant metastases, or those who refuse participation or use of their samples for research may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicentric, exploratory study aims to identify molecular, cellular, and psychological-sociological variables that predict how patients with gastric cancer respond to chemotherapy. By integrating basic, translational, and psychological research, the study seeks to develop a tool for optimizing patient stratification and early prediction of therapy-resistant groups. It includes both retrospective and prospective cohorts of patients diagnosed with potentially resectable gastric adenocarcinoma. The study will analyze tissue samples and clinical data to uncover predictive markers and the impact of the patient's environment on treatment outcomes.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for gastric cancer patients, improving their response to chemotherapy.
How similar studies have gone: Other studies have shown promise in using interdisciplinary approaches to predict treatment responses in cancer, suggesting potential success for this novel methodology.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with diagnosis of histologically confirmed, potentially resectable adenocarcinoma of the stomach (GC) or the gastric-esophageal junction (GEJ) treated with the standard regimens (5-Fluoro-Uracil or Capecitabine + Oxaliplatin +/- Docetaxel) * Participant is willing and able to give informed consent for participation in the study (prospective and retrospective cohort) or Substitutive Informed Consent Declaration Form will be subscribed by the PI for patients that are not reachable * Male or Female, aged \>18 years * Availability of tissue samples and clinico-pathological data for retrospective cohort Exclusion Criteria: * Age \< 18 years * Early Gastric Cancer and T2 (if N0) * Linitis plastica * Positive peritoneal cytology or peritoneal involvement * Distant metastases * Patient refusal to participate * Patient refusal to the use of their own samples for research * Patient withdrawing from treatment plan whilst under therapy due to patient co-morbidities or failure to comply with clinical counselling * Patients with underlying pathologies rendering sampling of biological material either as endangering patient's clinical status or as unusable * Patients with mental illness hindering the capacity to provide precise information in questionnaires or successfully comply with caregiver's recommendations
Where it's running
-
IRST IRCCS UO Oncologia
Meldola, Italy Recruiting -
Centre Hospitalier Regional et Universitaire (CHRU)
Brest, France Not yet recruiting -
INSERM, Faculty of Medicine (UMR1078)
Brest, France Active not recruiting -
1st Department of Propaedeutic Surgery, National & Kapodistrian University of Athens (NKUA)
Athens, Greece Not yet recruiting -
AUSL Romagna, UO Oncologia
Ravenna, Italy Active not recruiting
Study contacts
- Study coordinator: Chiara Molinari
- Email: chiara.molinari@irst.emr.it
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer
This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.
-
Integrated genomic and clinical database for cancer biomarker discovery
Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.
-
Adding 2141-V11 to standard therapy for advanced esophageal, gastric, or gastroesophageal junction cancer
This study tests whether adding the drug 2141-V11 to standard anti-PD-1 therapy (with or without 5-FU) is safe for adults with advanced or metastatic esophageal, gastric, or gastroesophageal junction adenocarcinoma.
-
Guaraná Supplement for Cancer-Related Fatigue in People Undergoing Treatment
This study tests whether taking guaraná capsules helps reduce cancer-related fatigue and improve quality of life in adults with breast, lung, colorectal, or gastric cancer who are actively receiving treatment.
-
ABBV-253 in adults with advanced solid tumors
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.