Predicting treatment response in advanced gastric cancer
Predicting the Efficacy of Paclitaxel Plus Ramucirumab in Advanced Gastric Cancer.
This study is testing a blood test to see if it can help doctors figure out which patients with advanced gastric cancer will respond well to a specific combination treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy, ramucirumab |
| Locations | 1 site (Kurashiki, Okayama) |
| Trial ID | NCT06490055 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with advanced gastric cancer to establish a liquid-biopsy assay that predicts their response to the combination therapy of ramucirumab and paclitaxel. By analyzing small RNA from pre-treatment blood samples, the study aims to identify which patients are likely to benefit from this second-line treatment. This predictive tool could help avoid unnecessary treatment for patients who are unlikely to respond, allowing them to explore alternative therapeutic options. The study emphasizes the importance of personalized treatment approaches in managing advanced gastric cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 20 years with unresectable or recurrent gastric cancer who have not responded to first-line chemotherapy.
Not a fit: Patients with a life expectancy of less than three months or severe health complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable personalized treatment plans for patients with advanced gastric cancer, improving their chances of receiving effective therapies.
How similar studies have performed: Other studies have shown promise in using liquid biopsies for predicting treatment responses, suggesting this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. unresectable or recurrent GC histologically confirmed to be primary adenocarcinoma of the stomach. 2. age over 20 years. 3. Eastern Cooperative Oncology Group performance status score of 0-2. 4. written informed consent following full study information is provided to the patient. 5. progression or intolerance for first-line chemotherapy comprising fluorinated pyrimidine and platinum anticancer drugs (cisplatin or oxaliplatin) for advanced GC. 6. presence of evaluable lesions as confirmed using a computed tomography (CT) or magnetic resonance imaging. Exclusion Criteria: 1. Patients with a life expectancy of shorter than 3 months 2. Patients with severe complications (angina pectoris, myocardial infarction, or arrhythmia) or uncontrollable diabetes mellitus, blood hypertension, or bleeding tendency. 3. Patients with a history of serious allergic reactions or serious drug allergy. 4. Patients with a clinically relevant mental disorder that prohibits response to questionnaires. 5. Patients for whom the attending physician considered that enrollment in the study is inappropriate.
Where this trial is running
Kurashiki, Okayama
- Kawasaki Medical University — Kurashiki, Okayama, Japan (Recruiting)
Study contacts
- Principal investigator: Koichi Takiguchi, PhD — City of Hope Medical Center
- Study coordinator: Ajay Goel, PhD
- Email: AJGOEL@COH.ORG
- Phone: 6262183452
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.