Analyzing blood and tumor markers to predict response to immunotherapy in advanced cancer
Analysis of PD-L1, TMB, CTDNA in Immunotherapy Response Monitoring and Prediction in Advancer Lung Cancer Treatment.
This study is testing if blood and tumor markers can help predict how well people with advanced cancer will respond to immunotherapy treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Gene Solutions Industry-sponsored |
| Drugs / interventions | Durvalumab, chemotherapy |
| Locations | 2 sites (Ho Chi Minh City, Hồ Chí Minh and 1 other locations) |
| Trial ID | NCT06227728 on ClinicalTrials.gov |
What this trial studies
This observational clinical trial aims to investigate the dynamics of circulating tumor DNA (ctDNA) alongside conventional tumor markers such as PD-L1, tumor mutational burden (TMB), and microsatellite instability (MSI) to predict and monitor responses to immune checkpoint inhibitors (ICIs) in patients with stage IV cancer. Participants will provide blood samples and tumor tissue for analysis at multiple time points, allowing researchers to assess changes over the course of treatment. The study will follow patients for two years, collecting demographic and medical history data to evaluate the effectiveness of these biomarkers in predicting treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with stage IV non-small cell lung cancer, breast cancer, colorectal cancer, gastric cancer, or liver cancer who are eligible for immune checkpoint inhibitors.
Not a fit: Patients who have already started immunotherapy or chemotherapy prior to enrollment will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for predicting patient responses to immunotherapy, potentially leading to personalized treatment plans.
How similar studies have performed: Other studies have shown promise in using ctDNA and tumor markers to predict responses to immunotherapy, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older, both genders. * Patients are diagnosed with stage IV cancer (lung, colorectal, breast, liver, gastric…) and indicated for ICI (first or second line). Concurrent chemotherapy with ICI is allowed. * FFPE/FNA sample is available. * Compliant with treatment protocol. * Patients consented to participate in the study. Exclusion Criteria: * Patients already started ICI before enrollment. * Consolidation ICI (eg. Durvalumab). * Patients already started chemotherapy before enrollment. * Medical or psychiatric conditions or occupational responsibilities that may preclude compliance with the protocol. * Patients did not agree to participate in the studies.
Where this trial is running
Ho Chi Minh City, Hồ Chí Minh and 1 other locations
- University of Medicine and Pharmacy at HCMC — Ho Chi Minh City, Hồ Chí Minh, Vietnam (Recruiting)
- Medical Genetics Institute — Ho Chi Minh City, Vietnam (Not_yet_recruiting)
Study contacts
- Principal investigator: Sinh D Nguyen — Mgi
- Study coordinator: Lan NL Tu, PHD
- Email: lantu@genesolutions.vn
- Phone: +84888843489
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.