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Search / Trial NCT04871321

Biomarker Discovery in Patients With Advanced Biliary Tract Cancer

Launched by CHA UNIVERSITY · Apr 29, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Biliary Tract Cancer Gemcitabine Cisplatin Nab Paclitaxel Rna Sequencing Biomarker

ClinConnect Summary

This clinical trial is focused on understanding advanced biliary tract cancer, which includes types like gallbladder cancer and cholangiocarcinoma. The researchers aim to discover important biological markers that could help improve treatment for patients with this type of cancer. Currently, the standard treatment involves a combination of chemotherapy drugs, but many patients do not have a good outcome, with survival rates being less than a year. This study is looking into a new treatment approach that combines three chemotherapy drugs and also explores the genetic features of the cancer to see how they might affect treatment response.

To participate in this trial, patients need to be at least 19 years old and have a confirmed diagnosis of inoperable or advanced biliary tract cancer. They should also be planning to receive the new combination of chemotherapy. Participants will undergo testing to see how their cancer behaves on a genetic level and will receive close monitoring throughout the treatment process. It's important to note that patients with certain health conditions or those who have already received specific types of treatment may not be eligible for this study. Overall, this trial aims to gather valuable information that could lead to more effective treatments for biliary tract cancer in the future.

Gender

ALL

Eligibility 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.

About Cha University

CHA University is a leading research institution dedicated to advancing medical science and improving patient care through innovative clinical trials. With a strong emphasis on collaboration and interdisciplinary approaches, CHA University engages in cutting-edge research across various fields, including oncology, cardiology, and regenerative medicine. The university fosters a dynamic environment for clinical research, driven by a commitment to ethical standards and patient safety, ensuring that all trials are conducted with the highest level of scientific rigor. Through its extensive network of healthcare professionals and state-of-the-art facilities, CHA University aims to contribute significantly to the development of new therapies and enhance the understanding of complex medical conditions.

Locations

Seongnam Si, Gyeonggi Do, Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Hongjae Chon, MD,PhD

Principal Investigator

CHA University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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