Maintenance Therapy in Metastatic Gastric Cancer: A Multicenter Retrospective Study in Colombia

NCT07856212 | Recruiting

• 1 other identifier: CCEI-18065-2025
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

Metastatic gastric cancer has a poor prognosis, and the cumulative toxicity of first-line platinum and fluoropyrimidine chemotherapy limits how long treatment can be continued. Maintenance therapy, in which patients whose disease is at least stable after induction chemotherapy continue on a less toxic regimen, is increasingly used, most often with fluoropyrimidines (capecitabine, 5-fluorouracil or S-1) and, in selected molecular subgroups, with immunotherapy or targeted therapy. Evidence on the outcomes of these strategies in Latin American patients is scarce. This multicenter retrospective study will review the medical records of adults with metastatic gastric cancer treated between 2013 and 2023 at four high-complexity cancer centers in Bogotá, Colombia, who received maintenance therapy after achieving at least stable disease with induction chemotherapy. The study will describe the demographic, clinical, pathological and molecular characteristics of these patients and estimate overall survival, progression-free survival, treatment response, toxicity and mortality. The investigators will not assign or modify any treatment.

Conditions

Stomach Neoplasms; Gastric Adenocarcinoma; Metastatic Gastric Cancer

Keywords

Maintenance Therapy; Fluoropyrimidines; Capecitabine; Fluorouracil; S-1; Immunotherapy; Trastuzumab; Overall Survival; Progression-Free Survival; Latin America; Colombia

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  From start of maintenance therapy until death from any cause or last follow-up, assessed up to 10 years

Secondary Outcomes (5)

• Progression-Free Survival

  From start of maintenance therapy until disease progression, death or last follow-up, assessed up to 10 years

• Best Response to Maintenance Therapy

  From start of maintenance therapy until disease progression or end of maintenance, assessed up to 10 years

• Survival Rate at 6 Months and 1, 2, 3, 4 and 5 Years

  6 months and 1, 2, 3, 4 and 5 years after diagnosis

• Number of Patients With Adverse Drug Reactions During Maintenance Therapy

  From start of maintenance therapy until end of maintenance, assessed up to 10 years

• Cancer-Specific Mortality

  From diagnosis until death or last follow-up, assessed up to 10 years

Study Arms (1)

Maintenance Therapy Cohort

Drug: Fluoropyrimidine Maintenance Therapy; Drug: Immune Checkpoint Inhibitor Maintenance; Drug: Targeted Therapy Maintenance

Interventions

Fluoropyrimidine Maintenance Therapy DRUG

Fluoropyrimidine-based maintenance therapy (capecitabine, 5-fluorouracil or S-1) administered after induction chemotherapy in routine clinical practice. The study does not assign or modify treatment; exposure data are abstracted retrospectively from medical records.

Also known as: Capecitabine, 5-Fluorouracil, S-1

Maintenance Therapy Cohort

Immune Checkpoint Inhibitor Maintenance DRUG

Immune checkpoint inhibitors (such as nivolumab, pembrolizumab or atezolizumab) administered as part of maintenance therapy in routine clinical practice. The study does not assign or modify treatment.

Also known as: Nivolumab, Pembrolizumab, Atezolizumab

Maintenance Therapy Cohort

Targeted Therapy Maintenance DRUG

Targeted therapy (such as trastuzumab in HER2-positive disease) administered as part of maintenance therapy in routine clinical practice. The study does not assign or modify treatment.

Also known as: Trastuzumab

Maintenance Therapy Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with metastatic gastric cancer diagnosed and treated between 2013 and 2023 at four high-complexity cancer centers in Bogotá, Colombia (Hospital Universitario Fundación Santa Fe de Bogotá, Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo, Clínica del Country and Los Cobos Medical Center) who received maintenance therapy after achieving at least stable disease with induction chemotherapy.

You may qualify if:

• Patients older than 18 years diagnosed with metastatic gastric cancer at a participating institution between 2013 and 2023 who received fluoropyrimidines, immunotherapy or targeted therapy as maintenance therapy.
• At least stable disease according to RECIST criteria after initial induction treatment, with ECOG performance status of 2 or less, followed by maintenance therapy with fluoropyrimidines.
• Medical record showing institutional oncology follow-up.

You may not qualify if:

• Biopsies that do not meet the quality and adequacy criteria required for analysis.
• No clinical or imaging follow-up at the institution after diagnosis and treatment.
• Metastatic gastric cancer treated exclusively with palliative care without fluoropyrimidine maintenance chemotherapy.
• Discontinuation of fluoropyrimidine maintenance therapy before the first follow-up assessment because of toxicity or medical decision, without evaluation of treatment response.
• Death during the diagnostic process before tumor classification and staging were completed.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead
• Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo: collaborator
• Clínica del country: collaborator

Study Sites (4)

Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogotá, Bogota D.C., Colombia

RECRUITING

Clínica del Country

Bogotá, Bogota D.C., Colombia

RECRUITING

Hospital Universitario Fundación Santa Fe de Bogotá

Bogotá, Bogota D.C., Colombia

RECRUITING

Los Cobos Medical Center

Bogotá, Bogota D.C., Colombia

RECRUITING

Related Publications (1)

• Stocker G, Lorenzen S, Ettrich T, Herz AL, Longo F, Kiani A, Venerito M, Trojan J, Mahlberg R, Moosmann N, Chibaudel B, Kubicka S, Greil R, Daum S, Geissler M, Larcher-Senn J, Keller G, Lordick F, Haag GM. S-1 maintenance therapy in Caucasian patients with metastatic esophagogastric adenocarcinoma-final results of the randomized AIO MATEO phase II trial. ESMO Open. 2023 Jun;8(3):101572. doi: 10.1016/j.esmoop.2023.101572. Epub 2023 Jun 2.

  PMID: 37270871 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Fluorouracil; S 1 (combination); Nivolumab; pembrolizumab; atezolizumab; Trastuzumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Henry Alexander Vargas, MD

  Fundación Santa Fe de Bogotá

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Henry Alexander Vargas, MD

CONTACT

+57 601 6030303; henry.vargas@fsfb.org.co

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clinical Oncologist

Study Record Dates

• First Submitted: September 28, 2026
• First Posted: October 2, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CO (4)