Exploring chemotherapy effectiveness in advanced cholangiocarcinoma
Clinical Feasibility of Nab-paclitaxel Plus Gemcitabine-cisplatin Chemotherapy in Patients With Locally Advanced Cholangiocarcinoma and Discovery of Biomarkers
This study is testing if a specific combination of chemotherapy can help patients with advanced bile duct cancer become eligible for surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (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 | NCT05677217 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify patients with locally advanced cholangiocarcinoma who are treated with a combination of nab-paclitaxel and gemcitabine-cisplatin chemotherapy. It involves analyzing peripheral blood and tumor tissues at baseline and after every three cycles of treatment to discover biomarkers correlated with treatment response. The study seeks to determine the rate of conversion to surgical operability following this chemotherapy regimen, addressing the urgent need for predictive biomarkers in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 19 with confirmed inoperable locally advanced cholangiocarcinoma who are planning to receive the specified chemotherapy.
Not a fit: Patients with unstable systemic conditions, prior palliative chemotherapy for cholangiocarcinoma, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and surgical options for patients with locally advanced cholangiocarcinoma.
How similar studies have performed: While this approach is exploratory, previous studies have shown promise in using biomarkers to predict treatment response in advanced solid cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Those above the age of 19 who understand the purpose of the study and agree to participate in the collection of samples during the study. * Patients with histologically or cytologically confirmed inoperable locally advanced cholangiocarcinoma (gallbladder cancer, extrahepatic biliary tract cancer, intrahepatic biliary tract cancer) * Patients who underwent an NGS test with advanced cholangiocarcinoma tissues * Patients planning to be treated with nab-paclitaxel plus gemcitabine-cisplatin combination therapy * ECOG performance status 0 or 1 Exclusion Criteria: * Systemic condition accompanied by instability of vital signs such as infection or organ failure * Patients who have previously received palliative chemotherapy for cholangiocarcinoma * Those with mental/neurological conditions or dementia who have difficulties understanding and completing the consent form * Those who are assessed as not suitable for this study, at the discretion of the researcher
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: Hong Jae Chon, MD,PhD — CHA Bundang Medical Center
- Study coordinator: Hong Jae Chon, MD,PhD
- Email: minidoctor@cha.ac.kr
- Phone: 82-031-780-3928
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.