Precise Treatment in Hepatobiliary Cancers (PTHBC)

NCT02715089 | Unknown DMC

• 1 other identifier: PM1503
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Neoplasms; Biliary Tract Neoplasms; Hepatobiliary Neoplasms

Keywords

NGS; Liver Neoplasms; Biliary Tract Neoplasms; Hepatobiliary Neoplasms

Outcome Measures

Primary Outcomes (2)

• Objective response rates (ORR)

  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)

  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 Outcomes (4)

• Overall survival (OS)

  Through study completion, an average of 1 year.

• Duration of Response (DOR)

  6 months

• Disease control rate (DCR)

  6 weeks

• Adverse Drug Reaction (ADR)/Adverse Event (AE)

  Through study completion, an average of 2 years.

Study Arms (1)

Precise treatment

All patients should accept next-generation sequencing (NGS) test before treatment.

Genetic: Precise treatment

Interventions

Precise treatment GENETIC

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

Precise treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subjects : Hepatobiliary Cancer patients.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• 3D Medicines: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31068370 DERIVED

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.

MeSH Terms

Conditions

Liver Neoplasms; Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Biliary Tract Diseases

Study Officials

• Hai-Tao Zhao, Doctor

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Xie, Doctor

CONTACT

+86-15010856596; xieyuan1988@sina.cn

Xiao-Bo Yang, Doctor

CONTACT

+86-13811675126; yangxiaobo67@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2016
• First Posted: March 22, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

CN (1)