Clinical Trial: The Effect of Individualized Precision Therapy Programs in Patients With BTC

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: RenJi Hospital

Current Primary Outcome: Overall Survival (OS) [ Time Frame: through study completion, an average of 2 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Progression-Free Survival (PFS) [ Time Frame: through study completion, an average of 2 year ]

Original Secondary Outcome: Same as current

Information By: RenJi Hospital

Dates:
Date Received: October 20, 2016
Date Started: December 2016
Date Completion: December 2019
Last Updated: October 21, 2016
Last Verified: October 2016