Back to resultsThe Effect of Individualized Precision Therapy Programs in Patients With BTC
Primary Purpose
Biliary Tract Neoplasms
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Individualized Precision Therapy Programs
Sponsored by
About this trial
This is an interventional treatment trial for Biliary Tract Neoplasms focused on measuring bile duct tumor, individualized precise treatment programs
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
Sites / Locations
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPTP Group
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Survival (OS)
The time from surgery to all-cause death
Secondary Outcome Measures
Progression-Free Survival (PFS)
The time from surgery to recurrence.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02943031
Brief Title
The Effect of Individualized Precision Therapy Programs in Patients With BTC
Official Title
The Effect of Individualized Precision Therapy Programs in Patients With Biliary Tract Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Neoplasms
Keywords
bile duct tumor, individualized precise treatment programs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPTP Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Individualized Precision Therapy Programs
Intervention Description
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 Measure Information:
Title
Overall Survival (OS)
Description
The time from surgery to all-cause death
Time Frame
through study completion, an average of 2 year
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
The time from surgery to recurrence.
Time Frame
through study completion, an average of 2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Chen, M.D.
Phone
+8613601779874
Email
dr_chentao78@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIAN WANG, M.D.
Organizational Affiliation
Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Chen, MD.
Email
dr_chentao78@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Individualized Precision Therapy Programs in Patients With BTC
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