National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer

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Brief Title

National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer

Official Title

A National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer (PLC)

Brief Summary

      Background:

      Primary Liver Cancer is the second most common cause of cancer-related death worldwide. It is
      the cancer with the fastest rising incidence and mortality in the United States. Researchers
      want to learn more about liver cancer to help them design better treatments.

      Objective:

      To better understand liver cancer.

      Eligibility:

      People ages 18 and older who have liver cancer and had or are planning to have immune therapy

      Design:

      Participants will be screened with a review of their medical records. They will be asked
      about their medical history and test results.

      Participants will come to the NIH Clinical Center. During this visit, their medical records,
      test results, imaging studies, and tissue samples (if available) will be gathered.
      Participants will learn the results of a test to see if they have any mutations known to be
      connected to cancer. They will learn if there are treatment options for them. Participants
      will give blood, urine, and stool samples or rectal swabs.

      Participants will not have follow-up visits just for this study. If they join another NIH
      research study and have visits for this other study, their medical records; test results; and
      blood, urine, and stool samples may be collected. This will occur about every 3 months. If
      they have a biopsy or surgery on another study or as part of treatment and there is leftover
      tissue, researchers would like to collect some of that tissue.

      Participants will be contacted every 6 months by phone or e-mail. They will be asked about
      their health. They will provide any medical records, test results, and imaging studies.

      Participants will be followed on this study for life.
    

Detailed Description

      Background:

      Primary liver cancer (PLC) is the 2nd most common cause of cancer-related death worldwide and
      the one cancer with the fastest rising incidence and mortality in the U.S. PLC consists of
      two main histological subtypes, i.e., hepatocellular carcinoma (HCC) and cholangiocarcinoma
      (CCA), in which diagnoses and treatment decisions are solely based on their baseline clinical
      features. However, whether these subtypes are truly distinct or share some fundamental
      features which can be pursued to improve clinical management is currently unclear. In
      addition, chronic liver diseases, due to complex etiologies such as viral hepatitis, alcohol
      consumption, chemicals, parasites or dietary factors, underlie and contribute to liver
      damage, increasing the risk of HCC and CCA development and progression. Consequently, PLC is
      clinically and biologically heterogeneous which has impeded biological assessment and
      clinical treatment.

      Despite considerable efforts towards improving diagnosis and development of new treatment
      modalities, the improvement of PLC patient survival is minimal. For certain patients at early
      or intermediate disease stages, resection and percutaneous local ablation or Transarterial
      chemoembolization are available. However, the majority of patients present at advanced stages
      of disease, where the current gold standard of treatment is sorafenib, providing only a
      minimal improvement in survival time. PLC therefore remains among the most difficult-to-treat
      malignancies, with a 5-year survival rate of less than 15% in the United States. Thus, it is
      imperative that new treatment modalities are developed to limit cancer development and treat
      advanced PLC.

      Immunotherapy (IO) is a promising new approach in PLC treatment. Alterations of the immune
      system, a component of the revised hallmarks of cancer, is recognized as a central player in
      carcinogenesis and cancer progression. Thus, strategies to inhibit or re-direct the immune
      response to the presence of tumors are currently being employed or developed.
      Immune-checkpoint inhibitors have shown promise in clinical trials of several solid tumors.
      Of particular note are monoclonal antibody-based therapy to block immune-inhibitory
      molecules, including programmed cell death protein-1 (PD-1), programmed cell death 1 ligand 1
      (PDL-1) and cytotoxic T lymphocyte antigen 4 (CTLA4), which block anti-tumor T cell activity.
      However, the capacity of these therapies to reduce incidence and progression of PLC are still
      relatively unknown. Currently, several trials are underway to study the impact of immune
      checkpoint inhibitors as single agents or in combination with targeted therapy, on PLC
      development and outcome. Initial findings from Phase I/II clinical trials of PLC are
      promising but suggest that only certain patients respond to such treatment regimens while
      others do not or suffer from resistance/relapse. At the moment, it is difficult to determine
      which patient may benefit from immune therapy, due in large part to the lack of large
      comprehensive studies, biobank resources of specimens and biospecimen collection in clinical
      trial protocols, which deter our ability to understand and define critical genomic or genetic
      factors that contribute to patient response. Hence, we plan to collect PLC patient specimens
      and clinical data from those undergoing immunotherapies at NIH Clinical Center and a few
      extramural clinical sites to develop predictors for (a) response or resistance to
      immunotherapy and (b) acquired resistance to immunotherapy.

      Objective:

      To establish a biospecimen repository for genomic, genetic and epigenetic analysis to study
      the biology of PLC development and progression.

      Eligibility:

      Patients with histologically/ultrasound/imaging confirmed or suspicious lesions of HCC or
      CCA.

      Patients with planned or a history of at least 1 dose of immunotherapy for HCC or CCA.

      Age >= 18 years old at date of study consent

      Design:

      This will be a long-term multi-center study to comprehensively study patients with primary
      liver cancer (PLC).

      Participants will provide clinical information (including medical history, clinical tests,
      imaging studies and reports, surgical pathology reports, genetic test results).

      Tissue samples, blood, urine and fecal samples will be obtained from participants during this
      study.

      Broad spectrum of scientific experiments, including genomics, metabolome, microbiome and
      immune monitoring will be performed.

      Local physicians will be provided with test results of genomics panel evaluation (TruSight
      Oncology 500 (TSO-500).

      Since long-term follow-up of individuals with PLC is a major feature of the study, local
      sites intend to maintain active contact with study subjects for as long as possible. Patients
      will be followed throughout the course of their illnesses, with particular attention to
      patterns of disease recurrence and progression, response to therapies and duration of
      responses. National death index data can also be utilized to obtain patient outcome
      information.
    


Study Type

Observational


Primary Outcome

To establish a biospecimen repository for genomic, genetic and epigenetic analysis to study the biology of PLC development and progression

Secondary Outcome

 To estimate overall survival following immunotherapy for PLC

Condition

Hepatocellular Carcinoma


Study Arms / Comparison Groups

 1/ Cohort 1
Description:  Subjects with a diagnosis or suspicion of PLC

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

500

Start Date

July 28, 2021

Completion Date

December 31, 2025

Primary Completion Date

December 31, 2025

Eligibility Criteria

        -  INCLUSION CRITERIA:

          -  Patients with histologically/ultrasound/imaging confirmed or suspicious lesions of HCC
             or CCA.

          -  Patients with planned or a history of at least 1 dose of immunotherapy for HCC or CCA.

          -  Ability of subject to understand and the willingness to sign a written informed
             consent document.

          -  Age greater than or equal to 18 years old at date of study consent.

        EXCLUSION CRITERIA:

        - Patients with known HIV infection (as these patients may have abnormal test results which
        may confound the endpoints of this study)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Tim F Greten, M.D., (240) 760-6837, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04145141

Organization ID

200006

Secondary IDs

20-C-0006

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Tim F Greten, M.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

April 7, 2022