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The Effect of Individualized Precision Therapy Programs in Patients With BTC

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02943031
Enrollment
60
Registered
2016-10-24
Start date
2016-12-31
Completion date
2020-12-31
Last updated
2019-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Tract Neoplasms

Keywords

bile duct tumor, individualized precise treatment programs

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.

Interventions

OTHERIndividualized 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.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival (OS)through study completion, an average of 2 yearThe time from surgery to all-cause death

Secondary

MeasureTime frameDescription
Progression-Free Survival (PFS)through study completion, an average of 2 yearThe time from surgery to recurrence.

Countries

China

Contacts

Primary ContactTao Chen, M.D.
dr_chentao78@163.com+8613601779874

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026