The Effect of Individualized Precision Therapy Programs in Patients With BTC

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Individualized Precision Therapy Programs in Patients With Biliary Tract Cancer

Conditions
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Biliary Tract Neoplasms

Intervention / Treatment
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* Other: Individualized Precision Therapy Programs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPTP Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | The time from surgery to all-cause death | through study completion, an average of 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | The time from surgery to recurrence. | through study completion, an average of 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bile duct tumor, individualized precise treatment programs