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  • A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma - NCT02954094

    Primary Aims 1. Establish a longitudinal observational cohort to understand the natural history and management of HCC, including the safety and outcomes of HCC treatment interventions utilized in usual clinical practice Secondary Aims 1. Evaluate the impact of HCC treatment interventions and concomitant medications on comorbid conditions and liver function 2. Evaluate patient-reported outcomes measures during the natural course of HCC and management with HRQoL questionnaires 3. Establish a Biorepository Specimen Bank (BSB) Exploratory Aims 1. Investigate optimal type, duration, and sequence/combination of treatment interventions for HCC used in usual clinical practice 2. Perform biomarker analyses to identify potential markers predictive of response patterns or side effect profiles 3. Generate hypotheses that may lead to further investigations regarding natural course and treatment of HCC

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    • Protocol Number:
      001720

    • Phase:
      N/A

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

      1. Male or female patients, age ≥18 years 2. Patients with a histological/cytological or radiological diagnosis of HCC (mixed HCC cholangiocarcinoma may be included; patients who are candidates for surgical and non-surgical treatment, as well as those being followed without specific HCC therapy may be included)

    Exclusion Criteria:

      1. Inability to provide written informed consent

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Robert Wood Johnson University Hospital
    • Rutgers Cancer Institute
  • A Phase II Trial of Tislelizumab Consolidation after Liver-Directed Therapy for Hepatocellular Carcinoma. - NCT05366829

    Primary Objective: To determine if consolidation therapy with Tislelizumab following local therapy improves 1-year progression-free survival in patients with locally advanced, unresectable HCC. PFS is defined as the time from registration until the criteria for disease progression is met by mRECIST and RECIST v1.1 or death as a result of any cause. Secondary Objectives: 1.To determine if consolidation therapy with Tislelizumab after definitive therapy improves time to metastatic disease and overall survival (OS) and local control in subjects with localized, inoperable HCC. 2.To assess objective response rate, disease control rate, duration of response with consolidation therapy with Tislelizumab after local therapy in subjects with localized, inoperable HCC. 3.To assess the safety profile of Tislelizumab after definitive therapy. 4. To assess biomarker response as measured by Alpha fetoprotein (AFP), should the patient s tumor produce AFP. Exploratory Objectives: 1.To determine the strength by which the tumor molecular profile from NGS tissue prior to initiation of therapy correlates with treatment response. 2.To analyze ctDNA as a biomarker of response to therapy and early detection of disease progression.

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    • Protocol Number:
      072105

    • Principal Investigator:
      Salma Jabbour

    • Phase:
      Phase II

    • Scope:
      Local

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy single agent systemic

    • Drugs Involved:
      Tislelizumab (BGB-A317)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Each patient eligible to participate in this study must meet all the following criteria: 1. Written informed consent 2. Primary diagnosis of HCC, planned to receive radiation, treatment naïve to systemic therapy for HCC, prior TACE permitted 3. Hepatocellular carcinoma diagnosis by histologic findings and/or imaging criteria of LI-RADS 5 4. Eastern Cooperative Oncology Group performance status score of 0-2 5. Age>/=18 years 6. Child-Pugh class A liver function or B7, BCLC A-C or deemed not a candidate for surgery or liver transplantation 7. No extrahepatic metastasis detected on CT chest with or without IV contrast, abdomen and pelvis with IV and oral contrast (triphasic-if feasible based on kidney function), or MRI abdomen/liver and chest CT. 8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 6 months after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤ 7 days of first dose of study drug 9. Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 6 months after the last dose of tislelizumab. Males must agree not to donate or bank sperm during treatment with tislelizumab and for > 6 months after treatment stop. 10. Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1. 11. Demonstrate adequate bone marrow and organ function as defined below: 1. Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL 2. Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN
    • Calculate serum creatinine clearance using the standard Cockcroft-Gault formula. Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours 3. Hepatic - Serum total bilirubin ≤ 3 mg/dL , AST (SGOT) and ALT (SGPT) ≤ 5x ULN , Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose.

    Exclusion Criteria:

      1. Prior radiotherapy to the region of the liver that would result in excessive doses to normal tissues due to overlap of radiation therapy fields 2. Prior selective internal radiotherapy/hepatic arterial Yttrium therapy, at any time 3. Severe, active co-morbidity as per investigator 4. More than five discrete intrahepatic parenchymal foci of definite HCC or left/right or main portal vein thrombus 5. Direct tumor extension into the stomach, duodenum, small bowel or large bowel 6. Measurable common or main branch biliary duct involvement with HCC 7. Extrahepatic metastases or malignant nodes (that enhance with typical features of HCC) > 3.0 cm, in sum of maximal diameters (e.g. presence of one 3.4 cm metastatic lymph node or two 2 cm lung lesions). Note: benign non-enhancing periportal lymphadenopathy is not unusual in the presence of hepatitis and is permitted, even if the sum of enlarged nodes is > 2.0 cm. 8. Prior liver transplant 9. HIV positive 10. Immunodeficiency requiring chronic systemic therapy or that may relapse 11. Participants who have received prior immunotherapy. 12. Participants with clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention (e.g. paracentesis) to maintain symptomatic control a. Note: Participants with ascites who require pharmacologic intervention (e.g. diuretics) to maintain symptomatic control and who have been on stable doses of diuretics for two months days prior to the first dose of study treatment are eligible. 13. Participants with clinically meaningful encephalopathy 14. Participants who have undergone prior solid organ or bone marrow transplant except for patients with prior renal transplant for whom dialysis may be employed in the event of graft rejection. 15. Patients must have documented hepatitis virology status. a. Participants with active hepatitis B virus (HBV) infection must have a viral load < 500 IU/mL within 28 days prior to start of Tislelizumab and be on suppressive therapy (per local standard of care) for a minimum of fourteen days prior to start of study treatment and for the length of the study. b. Participants with co-infection with HBV and hepatitis C virus (HCV) are excluded. c. Participants with a history of HCV infection but with negative HCV RNA by PCR are considered non-infected with HCV and can enroll. 16. Participants with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible. 17. Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible. 18. Participants with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only are eligible provided: 1) rash covers < 10% of body surface area (BSA), disease is well controlled at baseline and requires only low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%). 19. Any malignancy ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (e.g. resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). 20. Treatment with a live, attenuated vaccine within four weeks prior to initiation of study treatment with Tislelizumab. 1. Note: Seasonal vaccines for influenza and COVID-19 are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed. 21. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug a. Note: Participants who are currently or have previously been on any of the following steroid regimens are not excluded: i. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) ii. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption iii. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non- autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen) 22. With uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or ≥ Grade 3 hypoalbuminemia ≤ 14 days before first dose of study drug 23. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc. 24. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. 25. Severe infections within 4 weeks before first dose of study drug, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. 26. Received therapeutic oral or intravenous antibiotics within two weeks before first dose of study drug 27. Any major surgical procedure requiring general anesthesia ≤ 28 days before first dose of study drug 28. Any of the following cardiovascular risk factors: a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before first dose of study drug e .Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug 29. Has received any herbal medicine used to control cancer within fourteen days of the first study drug administration 30. Participants with toxicities (because of prior anticancer therapy) which have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (e.g., alopecia, neuropathy and specific laboratory abnormalities) 31. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that, will be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs or result in insufficient or might impair compliance with study c conduct. 32. Concurrent participation in another therapeutic clinical study.

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Monmouth Medical Center
    • Community Medical Center
    • RWJ University Hospital Hamilton
    • RWJ University Hospital Somerset
    • Rutgers Cancer Institute
  • A Phase II, Open-Label, Multi-Cohort, Multicenter Study in Patients with Unresectable Heptocellular Carcinoma and CHILDPUGH B7 and B8 Cirrhosis. - NCT06096779

    Primary objective: - To evaluate the safety of the study treatments in Cohorts A and B. Secondary Objectives: - To evaluate the efficacy of the study treatments in Cohorts A and B. - To evaluate patient-reported tolerability of the study treatments in Cohorts A and B from the participants perspective. Exploratory Objectives: To identify biomarkers as follows: - Those associated with response to atezolizumab + bevacizumab or atezolizumab monotherapy. - Those that are early surrogates of efficacy, are associated with progression to a more severe disease state (i.e., prognostic biomarkers). OR - Those that can increase the knowledge of disease biology and drug safety in Cohorts A and B.

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    • Protocol Number:
      072309

    • Principal Investigator:
      Howard Hochster

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic Chemotherapy single agent systemic

    • Drugs Involved:
      Atezolizumab (MPDL3280A) BEVACIZUMAB

    Read Inclusion & Exclusion Criteria

    General Inclusion Criteria:

    • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
    • Disease that is not amenable to curative surgical and/or locoregional therapies
    • No prior systemic treatment (including systemic investigational agents) for locally advanced or metastatic and/or unresectable HCC
    • Measurable disease (at least one untreated target lesion) according to RECIST v1.1
    • ECOG Performance Status of 0-2 within 7 days prior to initiation of study treatment
    • Child-Pugh B7 or B8 cirrhosis at screening and within 7 days prior to study treatment
    • Adequate hematologic and end-organ function
    • Life expectancy of at least 12 weeks
    • Female participants of childbearing potential must be willing to avoid pregnancy and egg donation
    • Absolute neutrophil count ≥1.0 x 109/L (≥1000/μL) without granulocyte colony-stimulating factor support
    • Platelet count ≥ 50 × 109/L (50,000/μL) without transfusion
    • Hemoglobin ≥ 80 g/L (8 g/dL) AST and ALT ≤ 5 × upper limit of normal (ULN)
    • Serum bilirubin ≤ 3 × ULN
    • Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula)
    • Serum albumin ≥ 20 g/L (2.0 g/dL) without transfusion in the prior 3 months
    • INR ≤2.3

    General Exclusion Criteria:

    • Pregnancy or breastfeeding
    • Prior treatment with CD137 agonists or immune checkpoint blockade therapies
    • Treatment with investigational therapy within 28 days prior to initiation of study treatment
    • Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
    • Treatment with systemic immunostimulatory agents
    • Treatment with systemic immunosuppressive medication
    • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment
    • Inadequately controlled hypertension
    • Active or history of autoimmune disease or immune deficiency
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    • Participants who have a known concurrent malignancy that is progressing or requires active treatment, who have not completely recovered from treatment, or who have a significant malignancy history that, in the opinion of the investigator, should preclude participation.
    • Participants on preventative hormonal therapies (i.e., tamoxifen and other hormonal inhibitors) are not excluded.
    • Known fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
    • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
    • Prior allogeneic stem cell or solid organ transplantation
    • Actively listed for liver transplantation
    • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
    • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
    • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
    • Grade ≥3 hemorrhage or bleeding event within 6 months prior to initiation of study treatment
    • Hepatic encephalopathy is allowed if no active symptoms or stable within 3 months of study treatment
    • History, planned, or recommended placement of transjugular intrahepatic portosystemic shunt (TIPS) is excluded from Cohort A only. TIPS is acceptable in Cohort B.
    • Diagnostic Paracentesis is allowed. Therapeutic Paracentesis within 3 months is an exclusion criteria
    • Participants with ascites controlled on diuretics are allowed.
    • History of spontaneous bacterial peritonitis within last 12 months

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute
  • Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere ) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy. - NCT06040099

    Primary: - To assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab by assessment of PFS in participants with unresectable HCC amenable to locoregional therapy Secondary: - To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess ORR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess OS after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To further assess DoR after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy Exploratory: - To further assess the pattern of progressive disease after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy - To describe tumor and normal tissue absorbed radioembolization dose and its relationship with response and outcomes and liver volume changes after treatment. - To assess participant-reported diseaseand treatment-related symptoms and HRQoL in participants with unresectable HCC amenable to locoregional therapy

    View All Details

    • Protocol Number:
      072311

    • Principal Investigator:
      Sharon Li

    • Phase:
      Phase II

    • Scope:
      National

    • Applicable Disease Sites:
      Liver

    • Therapies Involved:
      Chemotherapy multiple agents systemic

    • Drugs Involved:
      BEVACIZUMAB MEDI4736 (Durvalumab)

    Read Inclusion & Exclusion Criteria

    Inclusion Criteria:

    • Participants with confirmed unresectable HCC
    • Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume.
    • Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR > 30%.
    • Participants with no evidence of extrahepatic disease on any available imaging
    • Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
    • Participants having Child-Pugh score class A.
    • Participants having ECOG performance status of 0 or 1 at enrollment
    • Adequate organ and marrow function

    Exclusion Criteria:

    • Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant.
    • Participants co-infected with HBV and HDV
    • Any history of nephrotic or nephritic syndrome.
    • Clinically significant (eg, active) cardiovascular disease
    • Participants with uncontrolled hypertension
    • History of hepatic encephalopathy
    • Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
    • Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
    • Participant has received any prior anticancer systemic therapy for unresectable HCC.
    • History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
    • History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment

    Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

    For further information about clinical trials, please contact us at 732-235-7356 or 844-CANCERNJ.

    • Cooperman Barnabas Medical Center
    • Rutgers Cancer Institute