Precise Treatment in Hepatobiliary Cancers (PTHBC) (PTHBC)

March 16, 2016 updated by: Peking Union Medical College Hospital

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.

Study Overview

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

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The subjects : Hepatobiliary Cancer patients.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Precise treatment
All patients should accept next-generation sequencing (NGS) test before treatment.
During screening stage, all patients should accept next-generation sequencing (NGS) test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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) .
6 weeks
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.
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.
6 months
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).
6 weeks
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.
Through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Hai-Tao Zhao, Doctor, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 28, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (Estimate)

March 22, 2016

Study Record Updates

Last Update Posted (Estimate)

March 22, 2016

Last Update Submitted That Met QC Criteria

March 16, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

The data have the gene mutations information of patients.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Neoplasms

Clinical Trials on Precise treatment

3
Subscribe