Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date February 28, 2016
First Posted Date March 22, 2016
Last Update Posted Date March 22, 2016
Study Start Date December 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2016)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: March 16, 2016)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Precise Treatment in Hepatobiliary Cancers (PTHBC)
Official Title Single Center, Single Arm, Open Study, to Explore and Evaluate the Precise Treatment in Hepatobiliary Cancers(PTHBC)
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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Retention:   Samples With DNA
Description:
The samples, both tissue(s) and blood of patients should be provided for the next-generation sequencing (NGS) test before screening.
Sampling Method Non-Probability Sample
Study Population The subjects : Hepatobiliary Cancer patients.
Condition
  • Liver Neoplasms
  • Biliary Tract Neoplasms
  • Hepatobiliary Neoplasms
Intervention Genetic: Precise treatment
During screening stage, all patients should accept next-generation sequencing (NGS) test.
Study Groups/Cohorts Precise treatment
All patients should accept next-generation sequencing (NGS) test before treatment.
Intervention: Genetic: Precise treatment
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 16, 2016)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02715089
Other Study ID Numbers PM1503
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: The data have the gene mutations information of patients.
Responsible Party Peking Union Medical College Hospital
Study Sponsor Peking Union Medical College Hospital
Collaborators 3D Medicines (Sichuan) Co., Ltd.
Investigators
Principal Investigator: Hai-Tao Zhao, Doctor Peking Union Medical College Hospital
PRS Account Peking Union Medical College Hospital
Verification Date March 2016