The Effect of Individualized Precision Therapy Programs in Patients With BTC

NCT02943031 | Unknown Phase 4 DMC

• 1 other identifier: IPTP-BTC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Neoplasms

Keywords

bile duct tumor; individualized precise treatment programs

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  The time from surgery to all-cause death

  through study completion, an average of 2 year

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  through study completion, an average of 2 year

Study Arms (1)

IPTP Group

EXPERIMENTAL

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

Interventions

Individualized Precision Therapy Programs OTHER

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.

IPTP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Bile Duct Diseases

Study Officials

• JIAN WANG, M.D.

  Department of Biliary-pancreatic Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Chen, M.D.

CONTACT

+8613601779874; dr_chentao78@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: October 24, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)