The Effect of Individualized Precision Therapy Programs in Patients With BTC

Shanghai Jiao Tong University

Status and phase: Unknown; Phase 4

Conditions: Biliary Tract Neoplasms

Treatments: Other: Individualized Precision Therapy Programs

Study type: Interventional

Funder types: Other

Identifiers

NCT02943031

IPTP-BTC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

IPTP Group

Experimental group

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.

Treatment:

Other: Individualized Precision Therapy Programs