Hepatocellular CarcinomaPhase 2NCT04913480
SBRT and Durvalumab for Inoperable/Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Durvalumab and Stereotactic body radiation therapy in people with Hepatocellular Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The investigators propose a phase II single-arm study on using stereotactic body radiation therapy in combination with durvalumab for inoperable/unresectable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Durvalumab and Stereotactic body radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Oct 2020to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients must have histologically or radiologically confirmed HCC. For radiological diagnosis of HCC, a contrast-enhanced computed tomography or magnetic resonance imaging is mandatory to demonstrate the early arterial enhancement in arterial phase and contrast washout in the porto-venous phase on the imaging.
- Inoperable or unresectable non-metastatic HCC (in the form of tumor resection or liver transplantation) amenable to stereotactic body radiation therapy given in 5 fractions. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorisation (e.g. Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Be >/= 18 years of age on day of signing informed consent.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- A stage C or earlier HCC based on Barcelona Clinic Liver Cancer (BCLC) staging system.
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- A Child-Pugh of 7 or less.
- Demonstrate adequate organ function as defined in Inclusion Criteria 7, all screening labs should be performed 28 days prior to study registration up to the first dose of study drug.
- Adequate serum hematological functions defined as:
- Absolute neutrophil count (ANC) ≥1.0 x 10^9/l
- Platelet ≥50 x 10^9/l
- Hemoglobin ≥9 g/dL
- Adequate serum biochemistry functions defined as:
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). <<This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.>>
- Serum aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤2.5 times of institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5 times of ULN
- Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
- Males:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
- Females:
- Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 times of ULN unless subject is receiving anticoagulant therapy as long as PT or activated partitional thromboplastin time (APTT) is within therapeutic range of intended use of anticoagulants. APTT ≤1.5 times of ULN unless subject is receiving anticoagulant therapy as long as PT or APTT is within therapeutic range of intended use of anticoagulants.
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 24 hours of study enrollment up to administration of the dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 31 weeks after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >1 year. The following age-specific requirements apply:
- Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 31 weeks after the last dose of study therapy.
- We will allow prior radiation to other sites, with no washout period, prior to study entry as long as the high dose regions of the prior and proposed radiation fields do not overlap. In patients where the prior high dose area would overlap with the high dose area of the intended radiation, a 4 month washout period will be required. The safety of such treatment will be at discretion of the treating radiation oncologist.
- Prior central nervous system (CNS) radiation is allowed as long as cumulative radiation doses do not exceed tolerance of critical structures as judged by the treating radiation oncologist.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Must have a life expectancy of at least 12 weeks.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment or 5 half-lives, whichever is shorter.
- Has a diagnosis of severe active scleroderma, lupus, other rheumatologic or autoimmune disease within the past 3 months before study recruitment. Patients with a documented history of clinically severe autoimmune disease or a syndrome requiring systemic steroids or immunosuppressive agents will not be allowed on this study. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement are not excluded from this study.
- Has had a prior monoclonal antibody, immunotherapy or immune checkpoint inhibitors before recruitment into this study .
- Has had prior chemotherapy or targeted small molecule therapy (including sorafenib or other anti-vascular endothelial growth factor inhibitor) within 3 weeks prior to administration of the study drug or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered agent. *Note: Subjects with permanent ≤ Grade 2 toxicities (e.g. neuropathy) or toxicities corrected through routine medical management (e.g. thyroid replacement for hypothyroidism), are an exception to this criterion and may qualify for the study. *Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. *Note: Subjects with ≤ Grade 2 amylase or lipase elevations abnormalities that have no corresponding clinical manifestations (e.g. manifestation of pancreatitis), are an exception to this criterion and may qualify for the study.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, indolent lymphomas, or in situ cervical cancer that has undergone potentially curative therapy
- Has a history of prior solid organ transplants with or without any episodes of graft-versus-host disease.
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- Has a history of allogeneic bone marrow transplantation and peripheral stem cell rescue, with or without any episodes of graft-versus-host disease.
- Has clinically significant or symptomatic ascites requiring either diuretic therapy or paracentesis.
- Has known active extra-hepatic metastases. Patients with treated extra-hepatic metastases which are stable and not requiring any systemic treatment for ≥ 4 weeks are eligible.
- Has known carcinomatous meningitis (also known as leptomeningeal carcinomatosis).
- Has an active infection requiring intravenous systemic therapy or hospital admission.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality, including psychiatric or substance abuse disorder, that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 31 weeks after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). Routine checking for Anti-HIV1 or Anti-HIV2 is not mandatory.
- Untreated hepatitis B infection. Patients with chronic hepatitis B infection (defined as HBsAg positive) are eligible if they have started anti-viral therapy for at least 1 month and is continuing anti-viral treatment throughout the whole duration of this study.
- Has received a live vaccine 30 days prior to the first dose of trial treatment.
- Has experienced Grade 4 toxicity on treatment with prior radiation.
- Has experienced Grade 3-4 intracranial toxicity (hypophysitis or CNS toxicity) with either prior intracranial radiation, anti programmed cell death-1 (PD-1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor therapy.
- Is taking >4mg/day of dexamethasone or its equivalent at the start of immunotherapy or has required >4mg/day of dexamethasone or its equivalent for 3 consecutive days within 1 week of starting treatment.
- Allergies and adverse drug reaction to the following: History of allergy to study drug components; History of severe hypersensitivity reaction to any monoclonal antibody.
- Prior systemic therapy utilizing an anti CTLA-4 or PD-1/PD-L1 agent or other forms of immunotherapy.
- Has had prior radiation therapy (defined as >1Gy) to the area planning to be treated with SBRT.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) (B) Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent (C) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Clinical Oncology, Queen Mary Hospital
Hong Kong
Victor Lee, MD, 852-2255-4352, vhflee@hku.hk
Mike Law, FRCR, 852-2255-5034, lawhc703@hku.hk
About this study
Official title: A Multi-centre Single-arm Phase II Study on Durvalumab (MEDI 4736) With Stereotactic Body Radiation Therapy (SBRT) in Patients With Inoperable/Unresectable Hepatocellular Carcinoma
The investigators propose a phase II single-arm study on using stereotactic body radiation therapy in combination with durvalumab for inoperable/unresectable hepatocellular carcinoma. In addition, the investigators will also measure the change in number and intensity of PD-L1-positive circulating tumor cells before and after stereotactic body radiation therapy and durvalumab and evaluate their correlation with treatment response.
Read the detailed description
Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Asia Pacific region, primarily because of high incidence of hepatitis B infection in this locality. Resection or liver transplantation is the standard treatment for operable/resectable disease. However more than 50% of HCC are inoperable, primarily because of poor liver function, limited normal liver reserve and advanced disease beyond resectability. Locoregional treatment including transarterial chemoembolization (TACE), percutaneous ethanol injection (PEI), radiofrequency ablation (RFA) and recently radio-embolization are acceptable options. However the response rate was just between 30-80% treated with these modalities. Also some patients are contraindicated to these local therapies. For instance, those who have poor liver function (Child-Pugh B) or have their tumors showing portal vein invasion/thrombosis are contraindicated to TACE. Those who had their tumors close to adjacent critical organs e.g. liver, stomach, duodenum, small bowel and gallbladder, etc were not candidates for RFA or percutaneous ethanol injection. In addition, those who had tumors >4cm or close to major vessels have high local recurrence after RFA. Stereotactic body radiation therapy (SBRT), with the use of highly conformal and precision radiation techniques with real-time tracing of patient and tumor position so as to offer a high radiation dose to the tumors while sparing the adjacent critical organs from necessary radiation.
Previous preclinical studies suggested synergism of anti-tumor activity between radiation therapy and immune checkpoint inhibitors. Immune checkpoint inhibitors are now comprehensively and extensively tested in combination with radiotherapy (RT) as well (NCT01935921, NCT01860430). It has been recently known that RT increases the expression of the major histocompatibility complex (MHC). In turn, the MHC class-I restricted tumor antigen-specific cells elicited by RT will upregulate interferons in the tumors. This radiation-induced local inflammation and tumor-specific effector T cells will provide an additional mechanism for tumor control by modification of the tumor vasculature. In addition, RT will increase dendritic cell surface antigen presentation to T cells and production of cytokines leading to recruitment and activation of leucocytes from peripheral blood and extravasation to tumor parenchyma. These are part of the mechanisms of abscopal effect, a phenomenon where the tumors at the sites far away from the irradiated sites also regress after localized radiotherapy. Having learnt from the pivotal PACIFIC trial on the use of consolidation therapy with durvalumab (anti-PD-L1 monoclonal antibody) which confirmed the efficacy and safety of combination of chemoradiation and immunotherapy for stage III non-small-cell lung cancer, it is prime time to consider incorporation of immune checkpoint inhibitors into concurrent chemoradiation for other solid tumors like HCC.
In view of the promising activity of SBRT and immune checkpoint inhibitors for HCC, we propose a phase II single-arm study on using durvalumab in combination with SBRT for inoperable/unresectable HCC. Recruited patients with receive durvalumab 750mg intravenously every 2 weeks, starting 1 week before SBRT, for a total of 26 cycles (1 year).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Durvalumab, Stereotactic body radiation therapy
- Keywords
- Immune checkpoint inhibitor, Stereotactic body radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles
Stereotactic body radiation therapyRadiation
Also called Stereotactic body radiotherapy
Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab and stereotactic body radiation therapy | Experimental | 1. Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles, starting 1 week before commencement of stereotactic body radiation therapy
2. Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days Receives: Drug: Durvalumab; Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 1 year
Progression-free survival at 1 year
Measured: 12 months
Secondary outcomes (6)
Best objective response
Best objective response
Measured: 36 months
Local control rate
Local control rate
Measured: 36 months
Liver failure-free rate
Liver failure-free rate
Measured: 36 months
Overall survival
Overall survival
Measured: 36 months
Incidence of treatment-related side effects
Incidence of treatment-related side effects as determined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: 36 months
Changes in PD-L1 and PD-1 positive circulating tumor cells before and after stereotactic body radiation therapy and durvalumab
Changes in PD-L1 and PD-1 positive circulating tumor cells before and after stereotactic body radiation therapy and durvalumab
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start15 Oct 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Combination of stereotactic body radiation therapy and immune checkpoint inhibitor for inoperable/unresectable hepatocellular carcinoma
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Victor H.F. Lee, The University of Hong Kong
- Investigators
- Victor Ho Fun Lee, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913480
- Sponsor's protocol ID
- UW 19-655
- Status last verified
- May 2021
- First submitted
- 22 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre Single-arm Phase II Study on Durvalumab (MEDI 4736) With Stereotactic Body Radiation Therapy (SBRT) in Patients With Inoperable/Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04913480
- Acronym / sponsor ID
- UW 19-655
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Immune checkpoint inhibitor, Stereotactic body radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a phase II single-arm study on using stereotactic body radiation therapy in combination with durvalumab for inoperable/unresectable hepatocellular carcinoma. In addition, the investigators will also measure the change in number and intensity of PD-L1-positive circulating tumor cells before and after stereotactic body radiation therapy and durvalumab and evaluate their correlation with treatment response.
Detailed description
Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Asia Pacific region, primarily because of high incidence of hepatitis B infection in this locality. Resection or liver transplantation is the standard treatment for operable/resectable disease. However more than 50% of HCC are inoperable, primarily because of poor liver function, limited normal liver reserve and advanced disease beyond resectability. Locoregional treatment including transarterial chemoembolization (TACE), percutaneous ethanol injection (PEI), radiofrequency ablation (RFA) and recently radio-embolization are acceptable options. However the response rate was just between 30-80% treated with these modalities. Also some patients are contraindicated to these local therapies. For instance, those who have poor liver function (Child-Pugh B) or have their tumors showing portal vein invasion/thrombosis are contraindicated to TACE. Those who had their tumors close to adjacent critical organs e.g. liver, stomach, duodenum, small bowel and gallbladder, etc were not candidates for RFA or percutaneous ethanol injection. In addition, those who had tumors >4cm or close to major vessels have high local recurrence after RFA. Stereotactic body radiation therapy (SBRT), with the use of highly conformal and precision radiation techniques with real-time tracing of patient and tumor position so as to offer a high radiation dose to the tumors while sparing the adjacent critical organs from necessary radiation.
Previous preclinical studies suggested synergism of anti-tumor activity between radiation therapy and immune checkpoint inhibitors. Immune checkpoint inhibitors are now comprehensively and extensively tested in combination with radiotherapy (RT) as well (NCT01935921, NCT01860430). It has been recently known that RT increases the expression of the major histocompatibility complex (MHC). In turn, the MHC class-I restricted tumor antigen-specific cells elicited by RT will upregulate interferons in the tumors. This radiation-induced local inflammation and tumor-specific effector T cells will provide an additional mechanism for tumor control by modification of the tumor vasculature. In addition, RT will increase dendritic cell surface antigen presentation to T cells and production of cytokines leading to recruitment and activation of leucocytes from peripheral blood and extravasation to tumor parenchyma. These are part of the mechanisms of abscopal effect, a phenomenon where the tumors at the sites far away from the irradiated sites also regress after localized radiotherapy. Having learnt from the pivotal PACIFIC trial on the use of consolidation therapy with durvalumab (anti-PD-L1 monoclonal antibody) which confirmed the efficacy and safety of combination of chemoradiation and immunotherapy for stage III non-small-cell lung cancer, it is prime time to consider incorporation of immune checkpoint inhibitors into concurrent chemoradiation for other solid tumors like HCC.
In view of the promising activity of SBRT and immune checkpoint inhibitors for HCC, we propose a phase II single-arm study on using durvalumab in combination with SBRT for inoperable/unresectable HCC. Recruited patients with receive durvalumab 750mg intravenously every 2 weeks, starting 1 week before SBRT, for a total of 26 cycles (1 year).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Combination of stereotactic body radiation therapy and immune checkpoint inhibitor for inoperable/unresectable hepatocellular carcinoma
| Arm | Type | Receives |
|---|---|---|
| Durvalumab and stereotactic body radiation therapy | Experimental | Drug: Durvalumab, Radiation: Stereotactic body radiation therapy1. Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles, starting 1 week before commencement of stereotactic body radiation therapy 2. Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Patients must have histologically or radiologically confirmed HCC. For radiological diagnosis of HCC, a contrast-enhanced computed tomography or magnetic resonance imaging is mandatory to demonstrate the early arterial enhancement in arterial phase and contrast washout in the porto-venous phase on the imaging.
- Inoperable or unresectable non-metastatic HCC (in the form of tumor resection or liver transplantation) amenable to stereotactic body radiation therapy given in 5 fractions. Prior locoregional therapy including radiofrequency ablation, transarterial chemoembolisation, radioembolisation is allowed provided that radiologically progressive disease is demonstrated following these locoregional therapies.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorisation (e.g. Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- Be >/= 18 years of age on day of signing informed consent.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
Key exclusion criteria (26 listed)
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment or 5 half-lives, whichever is shorter.
- Has a diagnosis of severe active scleroderma, lupus, other rheumatologic or autoimmune disease within the past 3 months before study recruitment. Patients with a documented history of clinically severe autoimmune disease or a syndrome requiring systemic steroids or immunosuppressive agents will not be allowed on this study. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement are not excluded from this study.
- Has had a prior monoclonal antibody, immunotherapy or immune checkpoint inhibitors before recruitment into this study .
- Has had prior chemotherapy or targeted small molecule therapy (including sorafenib or other anti-vascular endothelial growth factor inhibitor) within 3 weeks prior to administration of the study drug or who has not recovered (i.e., ≤Grade 1 or at baseline) from adverse events due to a previously administered agent. *Note: Subjects with permanent ≤ Grade 2 toxicities (e.g. neuropathy) or toxicities corrected through routine medical management (e.g. thyroid replacement for hypothyroidism), are an exception to this criterion and may qualify for the study. *Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. *Note: Subjects with ≤ Grade 2 amylase or lipase elevations abnormalities that have no corresponding clinical manifestations (e.g. manifestation of pancreatitis), are an exception to this criterion and may qualify for the study.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, indolent lymphomas, or in situ cervical cancer that has undergone potentially curative therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles | Drug | Durvalumab and stereotactic body radiation therapy |
| Stereotactic body radiation therapyAlso: Stereotactic body radiotherapyStereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days. | Radiation | Durvalumab and stereotactic body radiation therapy |
Primary outcome
Progression-free survival at 1 year
Time frame: 12 months
Progression-free survival at 1 year
6 secondary outcomes
Best objective response
Time frame: 36 months
Local control rate
Time frame: 36 months
Liver failure-free rate
Time frame: 36 months
Overall survival
Time frame: 36 months
Incidence of treatment-related side effects
Time frame: 36 months
Changes in PD-L1 and PD-1 positive circulating tumor cells before and after stereotactic body radiation therapy and durvalumab
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor Ho Fun Lee, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Stereotactic body radiation therapy in people with Hepatocellular Carcinoma, run by The University of Hong Kong at 1 site in Hong Kong.
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 30 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victor Ho Fun Lee, MD (852-2255-4352, vhflee@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival at 1 year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2021.