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

Learn more about:
Related Clinical Trial
Recurrence After Whipple’s (RAW): Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Head Malignancy Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care Prospective Evaluation of Biliary Tissue Sampling With ERCP Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture Liver Cancer Registry Platform Target Rare Cancer Knowledge Neoadjuvant Therapy in Biliary Adenocarcinoma BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery Efficacy of Fistulotomy for Biliary Cannulation A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Etomidate vs. Midazolam for Sedation During ERCP Loop-tipped Guidewire in Selective Biliary Cannulation Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm BKM120 in Cancers With PIK3CA Activating Mutations A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT PTFE Stents for Treatment of Malignant Biliary Strictures Irreversible Electroporation of Unresectable Liver Tumors Personal Resilience Empowerment Program Study Radiofrequency Ablation for Biliopancreatic Malignancy Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer In Vitro Models of Liver and Pancreatic Cancer Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Evaluation of Stereotactic Radiosurgery For Liver Malignancies Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD Margin Status After Pancreaticoduodenectomy for Cancer A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer A Study of TRK-950 in Patients With Advanced Solid Tumors Combined HCC-MFCCC Proton Therapy and Bevacizumab for Primary Liver Tumors Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases Fluorescence QRH-882260 Peptide Imaging in the Bile Duct A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer MRCP Diagnoses EHCC Better When Combined DWI Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours Comparison of Biliary Forceps Biopsy and Brush Cytology Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Endobiliary RFA for Unresectable Malignant Biliary Strictures A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma Clinical Effect and Safety of PDT and RFA for Unresectable EHCC Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma Trial of IRE in Cholangiocarcinoma Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer S-1 in Combination With Abraxane in Treating Cholangiocarcinoma Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy – (FIGHT-202) Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Study of Pembrolizumab and Olaparib in Bile Duct Cancer Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma ncRNAs in Exosomes of Cholangiocarcinoma Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

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, we
           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 3 years progression-free 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

October 29, 2020

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 or Legally Authorized Representative 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

May 13, 2020