The Effect of Individualized Precision Therapy Programs in Patients With BTC

Phase 4

• Conditions: Biliary Tract Neoplasms
• Interventions: Other: Individualized Precision Therapy Programs

• Registration Number: NCT02943031
• Lead Sponsor: RenJi Hospital

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.

Study Timeline

• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2016-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-16
• Last Update Posted: 2019-10-18
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPTP Group	Individualized Precision Therapy Programs	The IPTP Group will receive the 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.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion, an average of 2 year	The time from surgery to all-cause death

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	through study completion, an average of 2 year	The time from surgery to recurrence.

Trial Locations

Locations (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, China