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Liver NeoplasmsPTHBCNCT02715089

Precise Treatment in Hepatobiliary Cancers (PTHBC)

An observational study of Liver Neoplasms and Biliary Tract Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Precise treatment
How many people
30 participants
Where
1 siteChina
Study dates
Dec 2015to Dec 2018
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The subjects : Hepatobiliary Cancer patients.

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Yuan Xie, Doctor contact

+86-15010856596

xieyuan1988@sina.cn

Xiao-Bo Yang, Doctor contact

+86-13811675126

yangxiaobo67@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

    Yuan Xie, Doctor, +86-150-1085-6596, xieyuan1988@sina.cn

    Xiao-Bo Yang, Doctor, +86-138-1167-5126, yangxiaobo67@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: Single Center, Single Arm, Open Study, to Explore and Evaluate the Precise Treatment in Hepatobiliary Cancers(PTHBC)

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.

Read the 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.

Being tested
Precise treatment
Keywords
NGS, Liver Neoplasms, Biliary Tract Neoplasms, Hepatobiliary Neoplasms
Medical subject headings
Liver Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Precise treatmentGenetic

    During screening stage, all patients should accept next-generation sequencing (NGS) test.

Study groups in NCT02715089
Study groupRoleWhat they receive
Precise treatmentAll patients should accept next-generation sequencing (NGS) test before treatment.
Receives: Genetic: Precise treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rates (ORR)

    Defined as the percentage of patients whose tumors have a complete or partial response to treatment (RECIST v1.1) .

    Measured: 6 weeks

  2. 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.

    Measured: 8 months

Secondary outcomes (4)

  1. 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.

    Measured: Through study completion, an average of 1 year.

  2. Duration of Response (DOR)

    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.

    Measured: 6 months

  3. Disease control rate (DCR)

    Defined as the percentage of patients whose tumors have a complete or partial response，or stable disease to treatment (RECIST v1.1).

    Measured: 6 weeks

  4. Adverse Drug Reaction (ADR)/Adverse Event (AE)

    Patients with treatment-related adverse events as assessed by CTC-AE v4.0.

    Measured: Through study completion, an average of 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2016 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02715089
Sponsor's protocol ID
PM1503
Acronym
PTHBC
Status last verified
Mar 2016
First submitted
28 Feb 2016
Last updated
22 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: The data have the gene mutations information of patients.

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.

    PubMed 31068370

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Neoplasms and Biliary Tract Neoplasms, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yuan Xie, Doctor (+86-15010856596, xieyuan1988@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rates (ORR) (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02715089, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2016.

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