The Effect of Individualized Precision Therapy Programs in Patients With BTC

Biliary Tract Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02943031
• Other study ID #: IPTP-BTC
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: RenJi Hospital
• Contact: Tao Chen, M.D.
• Phone: +8613601779874
• Email: dr_chentao78[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	The time from surgery to all-cause death	through study completion, an average of 2 year
Secondary	Progression-Free Survival (PFS)	The time from surgery to recurrence.	through study completion, an average of 2 year