Exploring the precise medicine of patients with primary hepatobiliary cancer. And evaluate the efficacy and safety of individualized treatment regimens for primary hepatobiliary cancer based on next-generation sequencing.
The purpose of this study is to explore the precise treatment in hepatobiliary cancer patients and evaluate drug efficacy, 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. 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
OBSERVATIONAL
Enrollment
200
During screening stage, all patients should accept next-generation sequencing (NGS) test.
Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGProgression-free survival (PFS)
Time of progression will be obtained by telephone interview or medical treatment records.
Time frame: From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year
Overall Survival (OS)
Include all-cause death of patients in this study.
Time frame: 2 years
Objective response rates (ORR)
Percentage of patients whose tumors have a complete or partial response to treatment.
Time frame: From treatment initiation to CR or PR, up to 2 years
Disease Control Rate (DCR)
The proportion of patients who had either stable disease (SD) for ≥ 6 months, a CR or PR after initiation of treatment for HCC
Time frame: From treatment initiation to SD, CR or PR, up to 2 years
Duration of Response (DOR)
duration from the first assessment of the tumor was CR or PR to the time that the first assessment for PD or date of death from any cause
Time frame: From treatment initiation to PD, up to 2 years
Adverse Drug Reaction (ADR)/Adverse Event (AE)
Patients with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Through study completion, an average of 2 years.
Quality of Life (QoL) after treatment
The life quality of every subject will be assessed every 3 months according to the FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.
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Time frame: Through study completion, an average of 2 years.