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| Name | Class |
|---|---|
| 3D Medicines | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precise treatment | All patients should accept next-generation sequencing (NGS) test before treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precise treatment | Genetic | During screening stage, all patients should accept next-generation sequencing (NGS) test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rates (ORR) | Defined as the percentage of patients whose tumors have a complete or partial response to treatment (RECIST v1.1) . | 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. | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year. |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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The subjects : Hepatobiliary Cancer patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Xie, Doctor | Contact | +86-15010856596 | xieyuan1988@sina.cn | |
| Xiao-Bo Yang, Doctor | Contact | +86-13811675126 | yangxiaobo67@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hai-Tao Zhao, Doctor | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31068370 | Derived | Lin J, Shi J, Guo H, Yang X, Jiang Y, Long J, Bai Y, Wang D, Yang X, Wan X, Zhang L, Pan J, Hu K, Guan M, Huo L, Sang X, Wang K, Zhao H. Alterations in DNA Damage Repair Genes in Primary Liver Cancer. Clin Cancer Res. 2019 Aug 1;25(15):4701-4711. doi: 10.1158/1078-0432.CCR-19-0127. Epub 2019 May 8. |
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The data have the gene mutations information of patients.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 22, 2020 | |
| Reset | Jul 9, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 22, 2020 | Jul 9, 2020 |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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The samples, both tissue(s) and blood of patients should be provided for the next-generation sequencing (NGS) test before screening.
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.
| 6 months |
| Disease control rate (DCR) | Defined as the percentage of patients whose tumors have a complete or partial responseļ¼or stable disease to treatment (RECIST v1.1). | 6 weeks |
| Adverse Drug Reaction (ADR)/Adverse Event (AE) | Patients with treatment-related adverse events as assessed by CTC-AE v4.0. | Through study completion, an average of 2 years. |
| D008107 |
| Liver Diseases |
| D001660 | Biliary Tract Diseases |