Precise Treatment in Hepatobiliary Cancers (PTHBC) (PTHBC)
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|ClinicalTrials.gov Identifier: NCT02715089|
Recruitment Status : Unknown
Verified March 2016 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
|Condition or disease||Intervention/treatment|
|Liver Neoplasms Biliary Tract Neoplasms Hepatobiliary Neoplasms||Genetic: Precise treatment|
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 [Patient Registry]|
|Estimated Enrollment :||30 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Single Center, Single Arm, Open Study, to Explore and Evaluate the Precise Treatment in Hepatobiliary Cancers(PTHBC)|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
All patients should accept next-generation sequencing (NGS) test before treatment.
Genetic: Precise treatment
During screening stage, all patients should accept next-generation sequencing (NGS) test.
- Objective response rates (ORR) [ Time Frame: 6 weeks ]Defined as the percentage of patients whose tumors have a complete or partial response to treatment (RECIST v1.1) .
- Progression-free survival (PFS) [ Time Frame: 8 months ]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.
- Overall survival (OS) [ Time Frame: Through study completion, an average of 1 year. ]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.
- Duration of Response (DOR) [ Time Frame: 6 months ]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.
- Disease control rate (DCR) [ Time Frame: 6 weeks ]Defined as the percentage of patients whose tumors have a complete or partial response，or stable disease to treatment (RECIST v1.1).
- Adverse Drug Reaction (ADR)/Adverse Event (AE) [ Time Frame: Through study completion, an average of 2 years. ]Patients with treatment-related adverse events as assessed by CTC-AE v4.0.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715089
|Contact: Yuan Xie, Doctorfirstname.lastname@example.org|
|Contact: Xiao-Bo Yang, Doctoremail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Yuan Xie, Doctor +86-150-1085-6596 firstname.lastname@example.org|
|Contact: Xiao-Bo Yang, Doctor +86-138-1167-5126 email@example.com|
|Principal Investigator: Hai-Tao Zhao, Doctor|
|Principal Investigator:||Hai-Tao Zhao, Doctor||Peking Union Medical College Hospital|