NCT02943031

The Effect of Individualized Precision Therapy Programs in Patients With BTC

The Effect of Individualized Precision Therapy Programs in Patients With Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective cohort study. Patients who meet the inclusion criteria will be enrolled in this study. The samples of biliary tract tumors will be collected. Genome sequencing, mini-PDX and PDX will be performed according to the requirement of individualized precision therapy programs. Suitable drugs will be chose according to drug screening results. OS and PFS will be compared with traditional chemotherapy to evaluate the effect of individualized precision therapy programs.

Detailed description

In this prospective cohort study, patients who are eligible for inclusion criteria will enroll in the study. After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification, and then to develop individualized precise treatment programs. The investigators hope to achieve the following objectives: ① Through the establishment of Individualized Precision Therapy Programs to improve the overall survival of bile duct malignancy (BTC)； ② To study the molecular typing of the prognosis of biliary malignancy; ③ To construct a database of BTC gene bank, as well as for drug screening information.

Conditions

• Biliary Tract Neoplasms

Interventions

Type	Name	Description
OTHER	Individualized Precision Therapy Programs	After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification.OS and PFS will be recorded.

Timeline

• Start date: 2016-12-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-10-24
• Last updated: 2019-10-18

Locations

1 site across 1 country: China