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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precise medicine | All patients should accept next-generation sequencing (NGS) test before treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| precise medicine | Genetic | During screening stage, all patients should accept next-generation sequencing (NGS) test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Time of progression will be obtained by telephone interview or medical treatment records. | From treatment initiation for advanced or metastatic HCC to the first date of disease progression for any cause up to 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Include all-cause death of patients in this study. | 2 years |
| Objective response rates (ORR) | Percentage of patients whose tumors have a complete or partial response to treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed primary hepatobiliary cancer in Tongji Hospital, Wuhan with results of NGS tests.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bixiang Zhang, PhD | Contact | 86-027-83665293 | bixiangzhang@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wanguang Zhang | Tongji Hospital | Study Chair |
| Zeyang Ding | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hepatic Surgery Center, Tongji Hospital, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
The data have the gene mutations information of patients.
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D001661 | Biliary Tract Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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The samples, both tissue(s) and blood of patients should be provided for the High-Throughput Sequencing test before screening.
| 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 | 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 | 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. | 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. | Through study completion, an average of 2 years. |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D001660 | Biliary Tract Diseases |