Real-world Study for Patients With Advanced Hepatobiliary Tumors

  • STATUS
    Recruiting
  • End date
    Jul 27, 2022
  • participants needed
    2000
  • sponsor
    Peking Union Medical College Hospital
Updated on 27 January 2021

Summary

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.

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, and explore the clinical application value of targeted therapy and immunotherapy in advanced hepatobiliary tumors in real world.

Details
Condition Disease-Free Survival, Quality of life, Overall Survival, Objective Response Rate, Disease Control Rate, Duration of Response, Five-year Survival Rate, Five-year Survival Rate, quality-of-life, Five-year Survival Rate, Five-year Survival Rate, Five-year Survival Rate
Treatment Precision oncology including targeted therapy and immunotherapy
Clinical Study IdentifierNCT03892577
SponsorPeking Union Medical College Hospital
Last Modified on27 January 2021

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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