Real-world Study for Patients With Advanced Hepatobiliary Tumors

March 27, 2023 updated by: Peking Union Medical College Hospital

Real-world Study for Targeted Therapy and Immunotherapy in Patients With Advanced Hepatobiliary Tumors: a Multi-centers, Open-assess Observational Study.

The investigators design a large sample size study in the real-world to explore whether targeted therapy and immunotherapy can improve the survival, quality of life and drug safety of patients with advanced hepatobiliary tumors, and analyze the correlation between genetic variation and the effectiveness of therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is a multicenter, non-random, open and observational real-world study. It is estimated that 2000 patients with advanced hepatobiliary tumors will be enrolled in about 20 research centers. And it is planned to complete the enrollment within 2 years and it is expected that all enrolled subjects will reach the observation end point in 5 years.

After primary screening of all the patients, the investigators will further collect next-generation sequence(NGS) data and immunohistochemical data from the subjects, and enroll patients with any type of the following three treatment program: 1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject; 2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc; 3. Immunotherapy or immunotherapy combined with targeted therapy.

The investigators will collect subjects' data from assessment centers each month and the efficacy, quality of life, and safety of treatment will be evaluated.

This trial plans to conduct an interim analysis and final analysis after collecting 500 cases, 1000 cases, and 2000 subjects, 3000 subjects,and explore the clinical application value of targeted therapy and immunotherapy in advanced hepatobiliary tumors in real world.

Study Type

Observational

Enrollment (Anticipated)

3000

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

  • Name: Xiaobo Yang
  • Phone Number: 010-69156043 010-69156043
  • Email: zhaoht@pumch.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
        • Contact:
          • Xiaobo Yang
          • Phone Number: 010-69156043 010-69156043
          • Email: zhaoht@pumch.cn

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients With Advanced Hepatobilary Tumors.

Description

Inclusion Criteria:

Subjects must meet all of the following criteria：

  1. ≥18 years old, gender is not limited, and life expectancy is at least 6 months.
  2. Diagnosed as primary liver cancer or biliary malignant tumor by histopathology or confirmed by imaging as HCC (by the American Association for the Study of Liver Diseases or standard for the diagnosis and treatment of primary liver cancer 2017 in China).
  3. The Barcelona staging classification: class B-C.
  4. Child-Pugh classification: class A-B.
  5. At least one measurable lesion (RECIST v1.1)
  6. Unable to perform radical surgery or patient refuse surgery.

  7. Subjects need palliative treatment, and have received or are undergoing any of the following three treatments:

    • Monotherapy or combination therapy with targeted drug associated with genetic variation in the subject.
    • Or, treat with pan-target anti-vascular drugs, such as sorafenib, regorafenib, lenvatinib, apatinib.
    • Or, immunotherapy or immunotherapy combined with targeted therapy or (and) classical chemotherapy.
  8. Subjects volunteer to participate in the study and sign informed consent.

Exclusion Criteria:

Patients with one or more of the following criteria should be excluded:

  1. Patients with early hepatobiliary tumor.
  2. The Barcelona staging classification: class A.
  3. Child-Pugh classification: class C.
  4. Radical surgical resection.
  5. CT or MRI shows unclear tumor boundary or no measurable lesions (RECIST v1.1).
  6. Drug abuse, or any medical, psychological, or social condition that may affect the study, patient compliance, or even compromise the safety of the patient.
  7. Conduct other experimental drug treatments other than this test within 4 weeks before the start of the study; or participate in another clinical study that has an impact on the results of this study.
  8. Mental or medical instability makes patients unable or unwilling to sign informed consent.
  9. Patients after comprehensive assessment are considered by the investigators to be unsuitable for participating in the study.

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: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with advanced hepatobiliary tumors

2000 patients with advanced hepatobiliary tumors will be enrolled and the enroll patients should be treat with any type of the following three treatment program:

  1. Monotherapy or combination therapy with the targeted drug related to genetic variation of the subject;
  2. Treatment with pan-target anti-angiogenic drugs, such as sorafenib, regorafenib, lenvatinib, apatinib, etc;
  3. Immunotherapy or immunotherapy combined with targeted therapy or (and) chemotherapy.
Drug: Precision oncology including targeted therapy and immunotherapy
Therapeutic regimens are based on the clinicopathological features, genomic alterations, advices from multidisciplinary tumor board and willings from patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: two years
Time from the date of initial treatment to death for any cause.
two years
Progression-free Survival (PFS)
Time Frame: six months
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: one year
Percentage of subjects with complete response and partial response.
one year
Disease Control Rate (DCR)
Time Frame: six months
Percentage of subjects with complete remission, partial remission, or stable disease during treatment or within 30 days of termination of test drug.
six months
Incidence of Treatment-Emergent Adverse Event
Time Frame: one year
Percentage of subjects who develop any adverse events (CTCAE 4.0).
one year
Quality of Life (QoL) after treatment
Time Frame: one year
The life quality of every subject will be assessed every 3 months according to the 45-item FACT-Hep questionnaire, which assesses generic HRQL concerns and disease-specific issues.
one year

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Collaborators

OrigiMed

Investigators

  • Study Chair: Haitao Zhao, Chinese Academy of Medical Sciences & 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.

General Publications

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 (Actual)

July 1, 2017

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 27, 2019

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • JS-1391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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 Quality of Life

Clinical Trials on Precision oncology including targeted therapy and immunotherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe