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Hepatocellular CarcinomaPhase 4NCT05185505

Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria

A Phase 4 study testing Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma and Hepatocellular Cancer, run by The Methodist Hospital Research Institute at 2 sites in 2 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are undergoing evaluation for or waitlisted for liver transplantation will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE) or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesin 2 countries
Study dates
30 Jan 2023to 31 Oct 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged ≥18 years old at the time of signing Informed Consent Form
  • Measurable or evaluable disease per RECIST v1.1 or mRECIST of unresectable HCC outside of Milan criteria
  • Histologically or radiologically proven HCC, without extrahepatic disease. Patients who consent to a fresh tissue biospy, and under the discretion of the Investigators, will provide a baseline biopsy sample for diagnosis and correlative studies. Archival tumor tissue may be used to confirm HCC in patients who do not consent to a fresh tissue biopsy.
  • Prior remote LRT is allowed if new lesions or local disease recurrence are present. Participants may have received one TACE or TARE treatment within 8 weeks prior to enrollment, whether or not new lesions are present.
  • Must be undergoing evaluation for or waitlisted for liver transplantation
  • Eligible and suited to receive TACE or TARE procedure(s)
Show all 36Show fewer
  • Child-Pugh score ≤B7
  • Eastern Cooperative Oncology Group (ECOG) score 0-1
  • Life expectancy of ≥ 6 months
  • Adequate hematological and end-organ function, defined by the following laboratory test results obtained within 14 days prior to study initiation:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Lymphocyte count ≥ 0.5 x 10^9/L (500/μL)
  • Platelet count > 75 x 10^9/L
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin < 1.5 x upper limit of normal (ULN)
  • Aspartate transaminase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) < 2.5 x ULN
  • Serum albumin > 2.7 g/dL
  • Serum creatinine < 1.5x ULN
  • Urine dipstick for proteinuria ≤ 2+ unless a 24-hour urine protein < 1 g of protein is demonstrated
  • International normalized ratio (INR) ≤ 1.5 or partial thromboplastin time (PTT) ≤ 1.5 x ULN for patients not receiving anti-coagulation. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or PTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatment.
  • No history of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment
  • Negative HIV test at screening or transplant workup
  • Documentation of referral to the Transplant Hepatology team for appropriate evaluation and management of patients who have one or more of the following:
  • Positive hepatitis B surface antigen (HBsAg) test at screening
  • Positive total hepatitis B core antibody (HBcAb) test at screening followed by a positive hepatitis B virus (HBV) DNA test at screening. The HBV DNA test must be performed only for patients who have a negative HBsAg test and a positive total HBcAb test.
  • Positive hepatitis C virus (HCV) antibody test at screening followed by a positive HCV RNA test at screening. The HCV RNA test must be performed for patients who have a positive HCV antibody test.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, as defined below:
  • Women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 6 months after the final dose of atezolizumab/bevacizumab Females who receive a LT are required to maintain abstinence or contraception until the End of Study.
  • A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
  • Examples of contraceptive methods with a failure rate of <1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
  • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:
  • With a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of atezolizumab/bevacizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period. Males who receive a LT are required to maintain these criteria until the End of Study.
  • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of preventing drug exposure.
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Women of childbearing potential must have a negative serum or urine pregnancy test result within 14 days prior to initiation of study treatment.

Who cannot join

  • Known fibrolamellar HCC, sacromatoid HCC, or mixed cholangiocarcinoma and HCC
  • Previous systemic therapy for HCC prior to study enrollment
  • Planned or prior multi-organ transplant or prior solid organ or allogeneic stem cell transplantation
  • History of Grade ≥4 venous thromboembolism
  • History or evidence upon physical or neurological examination of central nervous system (eg seizures) unrelated to cancer unless adequately treated with standard medical therapy. Anticonvulsants (stable dose) are allowed.
  • Moderate or severe ascites
Show all 56Show fewer
  • History of hepatic encephalopathy
  • Inadequately controlled hypertension (defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg)
  • History of hypertensive crisis or hypertensive encephalopathy
  • Evidence of a Grade 2 or higher esophageal and/or gastric varices. Patients must have an esophagogastroduodenoscopy (EGD) within 6 months prior to initiating the study treatment. See Section 8.7.1.2. If the EGD shows Grade 2 or higher esophageal and/or gastric varices, patients will be excluded and will not receive study treatment but can be re-evaluated for enrollment after successful treatment of varices according to institutional guidelines.
  • Significant vascular disease (eg, aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to drug administration
  • Clinically significant cardiovascular disease, such as cerebrovascular accidents within 12 months prior to randomization, myocardial infarction within 12 months prior to randomization, unstable angina, New York Heart Association (NYHA) Grade II or greater CHF, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with study treatment
  • History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (ie, in the absence of therapeutic anticoagulation)
  • Major surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury within 28 days prior to initiation of study treatment, or anticipation of need for major surgical procedure during the Treatment Phase of the study
  • Treatment should not be initiated within 7 days of having a core biopsy or other minor surgical procedure.
  • Treatment should not be initiated within 2 days of placement of a vascular access device.
  • History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess, grade 2 or higher untreated esophageal or gastric varices or active GI bleeding within 6 months prior to treatment
  • Serious, non-healing wound, active ulcer, or untreated bone fracture
  • Other malignancy within 5 years prior to randomization, except for localized cancer in situ, such as basal or squamous cell skin cancer
  • Current or recent (<10 days prior to initiation of study treatment) use of aspirin (>325 mg/day), or clopidogrel (>75 mg/day). Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the INR and/or a PTT is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the patient has been on a stable dose of anticoagulants for ≥2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as apixaban (Eliquis®), dabigatran (Pradaxa®), and rivaroxaban (Xarelto®) is not recommended due to bleeding risk, unless approved by the treating physician and the primary investigator.
  • Pregnancy (positive pregnancy test) or lactation, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study drugs
  • Women of childbearing potential must have a negative serum or urine pregnancy test result within 28 days prior to initiation of study treatment.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
  • Patients with indwelling catheters (eg, PleurX®) are allowed
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium >12 mg/dL or corrected serum calcium >ULN)
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
  • Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
  • Patients with controlled Type 1 Diabetes Mellitus who are on an insulin regimen are eligible for the study
  • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (eg, patients with psoriatic arthritis are excluded) are eligible for the study provided all following conditions are met:
  • Rash must cover <10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
  • Active tuberculosis
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Treatment with a live, attenuated vaccine (eg, FluMist®) within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the Treatment Phase, with the following exceptions:
  • Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (eg, 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.
  • Patients who received mineralocorticoids (eg, fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known allergy or hypersensitivity to any component of the Atezlizumab and Bevacizumab formulation, such as a known hypersensitivity to Chinese hamster ovary cell products
  • Inability to comply with study and/or follow-up procedures
  • Active infection requiring IV antibiotics within 2 weeks prior to initiation.
  • Note: Placement of a vascular access device should be at least 2 days prior to initiation of study treatment.
  • Patients receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • History of leptomeningeal disease
  • Evidence of abdominal free air that is not explained by paracentesis or recent surgical procedure
  • History of intra-abdominal inflammatory process within 6 months prior to initiation of study treatment, including but not limited to active peptic ulcer disease, diverticulitis, or colitis.
  • Chronic daily treatment with a nonsteroidal anti-inflammatory drug (NSAID). Occasional use of NSAIDs for the symptomatic relief of medical conditions such as headache or fever is allowed
  • Uncontrolled tumor-related pain
  • Patients requiring pain medication must be on a stable regimen at study entry.
  • Symptomatic lesions (eg, bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

2 sites in 2 countries

United States1 site

  • Houston Methodist Research Institute

    Houston, Texas, 77030

Other trials in United States

Canada1 site

  • Toronto General Hospital, University Health Network

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

Official title: Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients With Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study

Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are undergoing evaluation for or waitlisted for liver transplantation will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE) or transarterial radioembolization (TARE). We hypothesize that atezolizumab and bevacizumab can appropriately bridge patients with HCC beyond MC to transplantation and not increase the risk of 1-year post-transplant rejection.

Read the detailed description

Hepatocellular carcinoma (HCC) represents the second most common cause of cancer-related death and accounts for over 80% of primary liver cancers worldwide. Curative treatment options include surgical resection in patients with well compensated liver function and radio frequency ablation in small tumors. However, in 90% of patients, HCC occurs in the setting of cirrhosis where optimal management remains liver transplantation (LT) with 5-year survival rates of approximately 80%. Despite the success of LT in treating HCC, only a small portion of patients fit into standard Milan Criteria to receive a LT due to 1) advanced-stage disease and/or large tumor size preventing/delaying organ allocation and 2) a lack of neoadjuvant (bridging) therapies that can effectively down-stage or delay tumor progression for patients while on the LT waiting list. The proposed clinical trial will evaluate the feasibility of using a combination of the chemotherapeutic interventions atezolizumab and bevacizumab in a group of patients with HCC who have tumors beyond the Milan Criteria (in brief, 5 - 10 cm), in order to appropriately bridge them to liver transplantation without increasing the risk of graft rejection within 1-year post-LT.

Keywords
Bevacizumab, atezolizumab, Neoadjuvant Therapy, Liver Neoplasms, Liver Transplantation
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq

    1200 mg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg administered every three weeks for up to 6 months (up to 8 cycles) during the liver transplant waiting period

Study groups in NCT05185505
Study groupRoleWhat they receive
Atezolizumab + BevacizumabExperimentalPatients will receive transarterial chemoembolization (TACE) or transarterial radioembolization (TARE) approximately every 3 months, with a maximum of 4 treatments, plus atezolizumab combined with bevacizumab. Atezolizumab and bevacizumab will commence at least 3 weeks post the first TACE or TARE. Thereafter, patients will proceed to cycles 1-3 of atezolizumab/bevacizumab every 3 weeks.
Receives: Drug: Atezolizumab; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection

    Whether the proportion of liver transplant patients who have acute allograft rejection is ≤30%

    Measured: Within 1 year after liver transplant

Secondary outcomes (10)

  1. Proportion of participants who experience treatment-emergent adverse events

    Number of patients who experience an FDA-defined adverse event due to the experimental treatment

    Measured: Within 90 days of study drug administration

  2. Objective Response Rate

    Combined incidence of partial response and complete response of tumors to therapy determined using modified RECIST (mRECIST) and RECIST 1.1 criteria, defined as combined incidence of partial and complete response

    Measured: 6 months post study drug initiation

  3. Proportion of participants who are removed from the liver transplant waiting list after initiating the atezolizumab/bevacizumab therapy

    Number of participants who had been on the liver transplant waitlist but are removed

    Measured: Through study completion, up to 4 years

  4. The proportion of participants who proceed to liver transplantation

    Participants who receive a liver transplant

    Measured: Through study completion, up to 4 years

  5. Proportion of the liver explant tissue containing necrotic tumors

    Number of livers explanted during liver transplant that are found to contain necrotic tumors via pathology

    Measured: Through study completion, up to 4 years

  6. Recurrence-free survival in patients receiving a liver transplant

    Measure of how many patients experience hepatocellular carcinoma recurrence

    Measured: Within 1 year after liver transplant

  7. Overall survival after liver transplant

    Number of patients who are still alive after receiving a liver transplant (taking into account death of any cause)

    Measured: Study enrollment to 1 year after liver transplant, time of liver transplant to 1 year after liver transplant

  8. Overall Survival after Study Enrollment

    Number of patients who are still alive after enrolling in the study (taking into account death of any cause)

    Measured: Through study completion, up to 4 years

  9. Tumor biomarkers

    Measurement of alpha fetoprotein tumor biomarker from blood samples

    Measured: At enrollment; at time of first dose of atezolizumab/bevacizumab; 3, 6, 9, 12, 15, 18, 21, 24, 30, 39 weeks after first dose; at time of liver transplant; 1, 6, and 12 months after liver transplant

  10. Immune Cell Biomarkers

    Measurement of biomarkers in immune cells gathered via blood samples: 1) PD-L1+ in CD4+ and CD8+ cells and 2) FOXP3, CD127, and IL-8 in T regulatory cells

    Measured: At enrollment; at time of first dose of atezolizumab/bevacizumab; 3, 6, 9, 12, 15, 18, 21, 24, 30, 39 weeks after first dose; at time of liver transplant; 1, 6, and 12 months after liver transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start30 Jan 2023
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05185505
Sponsor's protocol ID
PRO00032239
Other IDs
ML43352
Status last verified
Oct 2026
First submitted
10 Dec 2021
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Please contact the study principal investigator for questions regarding data sharing.

Publications

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Nordenstedt H, White DL, El-Serag HB. The changing pattern of epidemiology in hepatocellular carcinoma. Dig Liver Dis. 2010 Jul;42 Suppl 3(Suppl 3):S206-14. doi: 10.1016/S1590-8658(10)60507-5.

    PubMed 20547305

  • Sapisochin G, Bruix J. Liver transplantation for hepatocellular carcinoma: outcomes and novel surgical approaches. Nat Rev Gastroenterol Hepatol. 2017 Apr;14(4):203-217. doi: 10.1038/nrgastro.2016.193. Epub 2017 Jan 5.

    PubMed 28053342

  • Tecentriq [Package Insert]. South San Francisco, CA: Genentech, Inc.; 2020.

  • Avastin [Package Insert]. South San Francisco, CA: Genentech, Inc.; 2020.

  • Mazzaferro V, Regalia E, Doci R, Andreola S, Pulvirenti A, Bozzetti F, Montalto F, Ammatuna M, Morabito A, Gennari L. Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis. N Engl J Med. 1996 Mar 14;334(11):693-9. doi: 10.1056/NEJM199603143341104.

    PubMed 8594428

  • Sapisochin G, Goldaracena N, Laurence JM, Dib M, Barbas A, Ghanekar A, Cleary SP, Lilly L, Cattral MS, Marquez M, Selzner M, Renner E, Selzner N, McGilvray ID, Greig PD, Grant DR. The extended Toronto criteria for liver transplantation in patients with hepatocellular carcinoma: A prospective validation study. Hepatology. 2016 Dec;64(6):2077-2088. doi: 10.1002/hep.28643. Epub 2016 Jun 30.

    PubMed 27178646

  • O'Rourke JM, Shetty S, Shah T, Perera MTPR. Liver transplantation for hepatocellular carcinoma: pushing the boundaries. Transl Gastroenterol Hepatol. 2019 Jan 2;4:1. doi: 10.21037/tgh.2018.12.07. eCollection 2019. No abstract available.

    PubMed 30854488

  • Gorgen A, Rosales R, Sadler E, Beecroft R, Knox J, Dawson LA, Ghanekar A, Grant D, Greig PD, Sapisochin G. Patterns and Predictors of Mortality After Waitlist Dropout of Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation. Transplantation. 2019 Oct;103(10):2136-2143. doi: 10.1097/TP.0000000000002616.

    PubMed 30801510

  • Finn RS, Qin S, Ikeda M, et al. Imbrave150: Updated Overall Survival (Os) Data from a Global, Randomized, Open-Label Phase Iii Study of Atezolizumab (Atezo) + Bevacizumab (Bev) Versus Sorafenib (Sor) in Patients (Pts) with Unresectable Hepatocellular Carcinoma (Hcc). Journal of Clinical Oncology. 2021;39(3_suppl):267-267.

  • Opdivo [Package Insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2018.

  • Schwacha-Eipper B, Minciuna I, Banz V, Dufour JF. Immunotherapy as a Downstaging Therapy for Liver Transplantation. Hepatology. 2020 Oct;72(4):1488-1490. doi: 10.1002/hep.31234. No abstract available.

    PubMed 32171041

  • Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. doi: 10.1016/S0140-6736(16)00561-4. Epub 2016 Mar 4.

    PubMed 26952546

  • Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10.

    PubMed 26970723

  • Lee MS, Ryoo BY, Hsu CH, Numata K, Stein S, Verret W, Hack SP, Spahn J, Liu B, Abdullah H, Wang Y, He AR, Lee KH; GO30140 investigators. Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study. Lancet Oncol. 2020 Jun;21(6):808-820. doi: 10.1016/S1470-2045(20)30156-X.

    PubMed 32502443

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atezolizumab and Bevacizumab in people with Hepatocellular Carcinoma and Hepatocellular Cancer, run by The Methodist Hospital Research Institute at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 56 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Receiving Liver Transplant Experiencing Acute Rejection (time frame: Within 1 year after liver transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05185505, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.

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