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Clinical Trials/NCT02943031
NCT02943031
Unknown
Phase 4

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

RenJi Hospital1 site in 1 country60 target enrollmentDecember 2016

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Biliary Tract Neoplasms
Sponsor
RenJi Hospital
Enrollment
60
Locations
1
Primary Endpoint
Overall Survival (OS)
Last Updated
6 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
December 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pathological diagnosis of biliary malignancies
  • The expected survival time is longer than 3 months
  • PKS score\> 60 points
  • Willing to take part in the study

Exclusion Criteria

  • Can not or refuse to collect tumor samples
  • Refused to accept the relevant treatment method

Outcomes

Primary Outcomes

Overall Survival (OS)

Time Frame: through study completion, an average of 2 year

The time from surgery to all-cause death

Secondary Outcomes

  • Progression-Free Survival (PFS)(through study completion, an average of 2 year)

Study Sites (1)

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