Clincosm LogoSign in Get a demo

The Effect of Individualized Precision Therapy Programs in Patients With BTC

Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02943031
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
48
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Individualized Precision Therapy Programs
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Individualized Precision Therapy Programs in Patients With Biliary Tract Cancer
Actual Study Start Date :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: IPTP Group

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Overall Survival (OS) [through study completion, an average of 2 year]

    The time from surgery to all-cause death

Secondary Outcome Measures

  1. Progression-Free Survival (PFS) [through study completion, an average of 2 year]

    The time from surgery to recurrence.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai China

Sponsors and Collaborators

  • RenJi Hospital

Investigators

  • Principal Investigator: JIAN WANG, M.D., Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT02943031
Other Study ID Numbers:
  • IPTP-BTC
First Posted:
Oct 24, 2016
Last Update Posted:
Oct 18, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by RenJi Hospital
bile duct tumor
individualized precise treatment programs
Additional relevant MeSH terms:
Biliary Tract Neoplasms

Study Results

No Results Posted as of Oct 18, 2019