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Precise Treatment in Hepatobiliary Cancers (PTHBC) (PTHBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
3D Medicines (Sichuan) Co., Ltd.
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Liver Neoplasms Biliary Tract Neoplasms Hepatobiliary Neoplasms Genetic: Precise treatment

Detailed Description:

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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Precise treatment
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.




Primary Outcome Measures :
  1. 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) .

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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
The samples, both tissue(s) and blood of patients should be provided for the next-generation sequencing (NGS) test before screening.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The subjects : Hepatobiliary Cancer patients.
Criteria

Inclusion Criteria:

  • Age from 18 to 65, male or female.
  • Radiologically and pathologically confirmed as hepatobiliary cancers with stage IV.
  • Palliative care as the preferred.
  • The result of next-generation sequencing (NGS) test show the patient has gene mutation and also can be treated by the right commercial products that have been approved by the China Food and Drug Administration (CFDA) or the Food and Drug Administration (FDA).
  • ECOG performance status 0-2.
  • Life expectancy ≥3 months.
  • Voluntarily participate in the study and agree to sign informed consent form.

Exclusion Criteria:

  • Hepatobiliary cancer patient with stageI-III, or with any of the following items will not be eligible for screening.Such as, suitable for the treatment of radical resection, radical resection but evaluation unmeasurable.
  • The result of NGS test show the patient has no gene mutation, or has gene mutation but no medicine.
  • ECOG performance status ≥ 3.
  • Female patients who are pregnant or not using a contraceptive method of birth control.
  • History or presence of serious cardiovascular or cerebrovascular abnormalities.
  • Abnormalities of the hepatic or renal functions, such as jaundice, ascites, bilirubin ≥ 1.5×ULN, alkaline phosphatase ≥ 3×ULN, persistent protein urine≥ grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0), creatinine ratio > 3.5g/24 hours, renal failure.
  • Persistent infection > grade 2 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0).
  • Patient has underwent a major operation 4 weeks prior to screening or has not yet recovered from the operation.
  • Patient with epilepsy, known or untreated brain metastases.
  • The presence of wounds, ulcers or fractures that can not be healed, or with a past history of transplantation.
  • The presence of bleeding events ≥grade 3 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0) , present evidence or past history of coagulation dysfunction disorders.
  • Known human immunodeficiency virus (HIV) infection history.
  • Patient with drug abuse or unstable compliance.
  • The presence of unresolved toxicity caused by any previous treatment/operation > grade 1 (according to National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTC-AE] v4.0), except alopecia, anemia or hypothyroidism).
  • Investigator consider that the patient should not be enrolled in this study by careful assessment.
  • The subjects participate in any other clinical trial in the meantime.

Information from the National Library of Medicine

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


Contacts
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Contact: Yuan Xie, Doctor +86-15010856596 xieyuan1988@sina.cn
Contact: Xiao-Bo Yang, Doctor +86-13811675126 yangxiaobo67@pumch.cn

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yuan Xie, Doctor    +86-150-1085-6596    xieyuan1988@sina.cn   
Contact: Xiao-Bo Yang, Doctor    +86-138-1167-5126    yangxiaobo67@pumch.cn   
Principal Investigator: Hai-Tao Zhao, Doctor         
Sponsors and Collaborators
Peking Union Medical College Hospital
3D Medicines (Sichuan) Co., Ltd.
Investigators
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Principal Investigator: Hai-Tao Zhao, Doctor Peking Union Medical College Hospital
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02715089    
Other Study ID Numbers: PM1503
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data have the gene mutations information of patients.
Keywords provided by Peking Union Medical College Hospital:
NGS
Liver Neoplasms
Biliary Tract Neoplasms
Hepatobiliary Neoplasms
Additional relevant MeSH terms:
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Neoplasms
Liver Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Biliary Tract Diseases