The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug safety, progression free and overall survival. This trial study is based on genetic tests, then therapeutic target drugs are administered according to the genetic test reports. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit from precise treatment which targets particular genetic abnormality. The identifications of these genetic abnormalities may help treat hepatobiliary cancer patients better.
The genetic tests are performed for the eligible subjects in this study, then therapeutic target drugs are administered according to the genetic test reports. While the precise treatments, follow-ups are conducted to evaluate the efficacy and safety of the target drugs for the subjects, until the overall survival. Study Type: Non-Interventional. Masking: Open Label.
Study Type
OBSERVATIONAL
Enrollment
30
During screening stage, all patients should accept next-generation sequencing (NGS) test.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective response rates (ORR)
Defined as the percentage of patients whose tumors have a complete or partial response to treatment (RECIST v1.1) .
Time frame: 6 weeks
Progression-free survival (PFS)
Progression-free survival (PFS) is the time that passes from the day in which the patient is enrolled in the trial until the date on which disease "progresses" or the date of death from any cause.
Time frame: 8 months
Overall survival (OS)
Overall survival (OS) is the duration from the day in which the patient is enrolled in the trial until the date of death from any cause.
Time frame: Through study completion, an average of 1 year.
Duration of Response (DOR)
Duration of Response (DOR) is the duration from the first assessment of the tumor was CR or PR to the time that the first assessment for PD (Progressive Disease) or date of death from any cause.
Time frame: 6 months
Disease control rate (DCR)
Defined as the percentage of patients whose tumors have a complete or partial response,or stable disease to treatment (RECIST v1.1).
Time frame: 6 weeks
Adverse Drug Reaction (ADR)/Adverse Event (AE)
Patients with treatment-related adverse events as assessed by CTC-AE v4.0.
Time frame: Through study completion, an average of 2 years.
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