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Clinical Trial Summary

Biliary tract cancer (BTC) compromises a heterogenous group of tumors with poor prognoses. Curative surgery remains the first choice for localized disease; however, most BTC patients had unresectable or metastatic disease. The gold standard therapy for these patients is chemotherapy with gemcitabine and cisplatin. There are no consensus guidelines for standard treatment in a second-line setting, although the data of the ABC-06 trial showed a slight survival benefit from oxaliplatin and 5-fluorouracil combination chemotherapy. Recent progress in comprehensive genomic profiling for advanced BTC has helped to clarify tumorigenesis and facilitate the coming era of precision medicine. To further elucidate the underlying molecular genomic aberrations, as well as the clinical demographics and therapeutic outcomes, it is necessary to have a national, multi-centers and population-focused research project to collect data completely. Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis in a platform of data storage and sharing. The purpose of the precision medicine project is to establish tumor molecular profiling of BTC populations in Taiwan, to facilitate patients to have corresponding potential targeted therapeutics and suitable clinical trials.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05036486
Study type Observational [Patient Registry]
Source National Health Research Institutes, Taiwan
Contact Ming-Huang Chen, MD, PhD
Phone 886-2-28757270
Email [email protected]
Status Not yet recruiting
Start date September 1, 2021
Completion date December 2030

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03314935 - A Phase 1/2 Study of INCB001158 in Combination With Chemotherapy in Subjects With Solid Tumors Phase 1/Phase 2
Recruiting NCT04004234 - A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC Phase 1/Phase 2