Surgery for advanced gastric cancer with liver metastases
Gastric Cancer and Oligometastatic Liverinvolvement. Metastatectomy and Impact on Survival
This study is testing if surgery to remove liver tumors can help people with advanced stomach cancer live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Aarhus, Jylland) |
| Trial ID | NCT06627634 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to provide a potential cure for patients with advanced gastric or gastroesophageal junction cancer that has spread to the liver. Participants will undergo metastatectomia, which involves the surgical removal of metastatic liver lesions, along with standard treatments such as neoadjuvant chemotherapy and gastrectomy. The study will include 20 patients from four centers in Denmark, focusing on those with resectable tumors and limited liver involvement. The primary endpoint is to evaluate the overall survival rate at two years post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with resectable T1-T4N0-N3M1 adenocarcinoma of the stomach or GEJ and a maximum of 30% liver involvement.
Not a fit: Patients with non-resectable cancer or significant growth into adjacent organs will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a curative treatment option for patients with limited metastatic gastric cancer.
How similar studies have performed: While similar approaches have been explored, this specific combination of metastatectomia and standard treatment for oligometastatic gastric cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18. * Presence of primary T1-T4N0-N3M1 adenocarcinoma of the stomach or GEJ and max. 30% liver involvement. * Primary tumour resectable, based on imaging workup. * Surgical operable patients with ASA-score36 ≤ III and WHO performance status37 0-1. * Patients eligible for treatment with systemic chemotherapy by FLOT regimen. * Informed consent is obtained. Exclusion Criteria: * Patient with non-resectable cancer. * Direct growth involving adjacent organs, i.e., pancreas, colon, blood vessels or bones. * Other malignant disease diagnosed or treated up to 2 years prior to inclusion, except non-aggressive cancers such as non-melanoma sin cancer. * Altered anatomy of the upper gastrointestinal tract due to previous surgery of the oesophagus, stomach, and duodenum. * BMI ≤ 18 * The patient is unable to understand and/or read the consent form. * Other serious illness or acute infections. * Pregnant or breastfeeding.
Where this trial is running
Aarhus, Jylland
- Aarhus Univercity hospital — Aarhus, Jylland, Denmark (Recruiting)
Study contacts
- Study coordinator: Julie Lykke Harbjerg, MD
- Email: Juharb@rm.dk
- Phone: +4520404424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.