Identifying biomarkers in patients with advanced biliary tract cancer
Discovery of Molecular Biomarkers for Predicting Response Through RNA Sequencing in Patients With Advanced Biliary Tract Cancer Who Received Nab-paclitaxel Plus Gemcitabine-cisplatin
This study is trying to find specific markers in patients with advanced biliary tract cancer to see how well they respond to chemotherapy and improve treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seongnam-si, Gyeonggi-do) |
| Trial ID | NCT04871321 on ClinicalTrials.gov |
What this trial studies
This observational study aims to discover biomarkers that predict responses to systemic chemotherapy in patients with advanced biliary tract cancer, including cholangiocarcinoma and gallbladder cancer. Utilizing biopsy specimens and advanced RNA sequencing techniques, the study will analyze multi-omics data to identify genetic alterations associated with treatment outcomes. Blood samples will also be collected to study cell-free DNA and circulating tumor cells at various stages of chemotherapy. The goal is to enhance understanding of the heterogeneity of biliary tract cancer and improve treatment strategies.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with inoperable or metastatic biliary tract cancer who are planning to receive a specific chemotherapy regimen.
Not a fit: Patients with prior palliative chemotherapy for biliary tract cancer or those with uncontrolled significant illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for patients with advanced biliary tract cancer, potentially improving survival outcomes.
How similar studies have performed: While the approach of using RNA sequencing for biomarker discovery is gaining traction, this specific application in biliary tract cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 19 years old * Capable of understanding and complying with the protocol requirements and signed informed consent * The patients were confirmed as bilary tract cancer (gall bladder cancer, extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma) by histopathology or cytology * Patients with inoperable or metastatic or recurrent biliary tract cancer * Patients who underwent in-house next-generation sequencing * Patients planning to receive Gemcitabine, Cisplatin, nab-paclitaxel triplet chemotherapy * At least one measurable objective lesion was identified based on the RECIST 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * The expected survival a ≥3 months Exclusion Criteria: * The subject has uncontrolled, significant intercurrent or recent illness including infection for organ failure * Prior palliative chemotherapy for biliary tract cancer * Dementia, altered mental state, or any mental illness that prevents understanding or informed consent * Other conditions that researchers not think to be suitable for enrollment.
Where this trial is running
Seongnam-si, Gyeonggi-do
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Hongjae Chon, MD,PhD — CHA University
- Study coordinator: Hong Jae Chon, MD,PhD
- Email: minidoctor@cha.ac.kr
- Phone: 82-31-780-3928
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.