NCT04871321Completed
Biomarker Discovery 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
Source: ClinicalTrials.gov · Last updated 26 Aug 2025
Brief summary (registry, in English)
Biliary tract cancer is a rare gastrointestinal malignant neoplasm and includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancer. Curative surgical resection offers the only chance for cure. However, most patients with BTC are diagnosed at an unresectable stage. Therefore, the survival outcomes of patients with advanced biliary tract cancer remain dismal. The combination of gemcitabine and cisplatin has become the current standard for advanced BTCs since the landmark ABC-02 trial in 2010. However, the median overall survival of Gem/Cis chemotherapy is less than 1 year. Recently, a triplet regimen of gemcitabine, cisplatin, and nab-paclitaxel showed promising results in a single-arm phase II multicenter study. However, biliary tract cancer is a group of heterogenous diseases by site and genetic alteration, and this diversity may lead differences in response to systemic chemotherapy. Transcriptome analysis through RNA-sequencing has rarely been performed in advanced biliary tract cancer, and even if it has performed, only small number of patients were included. Further research on multi-omics data is needed on the necessity and clinical significance in treatment of biliary tract cancer.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 119 (actual)
- First submitted
- 26 Apr 2021
- Start date
- 14 Apr 2021
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- CHA University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04871321
What you commit to
- Study type: Observational
- Participants enrolled: 119
- From 14 Apr 2021 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior palliative chemotherapy for biliary tract cancer
Other illness
- The subject has uncontrolled, significant intercurrent or recent illness including infection for organ failure
- 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.
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.