Hepatocellular CarcinomaPhase 2NCT05396937
Efficacy and Safety of T+A+RAD in HCC
A Phase 2 study testing Multifocal Stereotactic Radiotherapy, Atezolizumab Injection [Tecentriq] and Bevacizumab in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
Trial summary
This is An Open-label, Single-arm Exploratory Study to determine the efficacy and safety of Multifocal Stereotactic Radiotherapy Combined with Atezolizumab and Bevacizumab in the Treatment of Metastatic Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Multifocal Stereotactic Radiotherapy, Atezolizumab Injection [Tecentriq] and Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2022to Dec 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female between the ages of 18 and 70;
- signed informed consent;
- The researchers believe that patients have the ability to comply with the research program;
- hepatocellular carcinoma (HCC) by histological or cytological or clinical diagnosis;
- imaging examination confirmed extrahepatic dissemination, including at least one evaluable (according to the criteria of RECIST1.1) extrahepatic metastasis;
- disease is not suitable for radical surgery;
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- Patients who have not received radiotherapy or treatment with aletirizumab and/or bevacizumab;
- Early treatment allows tyrosine kinase inhibitors (TKI) treatment or immunotherapy;
- Pre-treatment tumor tissue samples (if available); If tumor tissue is available, submit 1 formalin-fixed, paraffin embedded (FFPE) tumor sample from a paraffin block (preferred) or approximately 10-15 slides containing unstained, off-the-shelf, serial sections together with a pathology report within 4 weeks of enrollment. If the FFPE samples described above are not available, samples of any type (including fine needle aspiration biopsy samples, cell mass samples [e.g., samples from pleural effusion], and irrigation samples) may also be accepted. A relevant pathology report shall be provided with the sample. If tumor tissue is not available (e.g., exhausted for previous diagnostic tests), the patient remains eligible to participate;
- ECOG performance status of 0 or 1 within 14 days before enrollment;
- Child-Pugh A or ≤ 7 grade B within 14 days before enrollment;
- sufficient hematology and organ function, based on the results of the following laboratory tests obtained within 14 days before enrollment (unless otherwise specified): absolute neutropcount (ANC) ≥ 1.5 × 109/L (1500/μL), without granulocyte colony-stimulating factor support; lymphocyte count ≥ 0.5 × 109/L (500/μL); platelet count ≥ 75 × 109/L (75, 000/μL) or ≥ 60 × 109/L (60, 000/μL) but normal prothrombin time without blood transfusion; hemoglobin ≥ 90 g/L (9 g/dL), in order to meet this criterion, Patients may be allowed to have blood transfusions; AST, ALT and alkaline phosphatase (ALT) ≤ 5 times the upper limit of the normal value; Serum bilirubin ≤ 3 times the upper limit of the normal value; Serum creatinine ≤ 1.5 times the upper limit of normal value or calculated creatinine clearance ≥ 50 mL/min (calculated using Cockcroft-Gault formula); Serum albumin ≥ 28 g/L (2.8 g/dL) Urine cellulose strip test results in proteinuria < 2 + (performed within 14 days prior to starting study treatment); patients with baseline cellulose strip test results of ≥ 2 + proteinuria should collect 24 hours of urine and then must demonstrate < 1g of urine protein in 24 hours.
- Any acute, clinically significant treatment-related toxicity (caused by previous treatment) must have been alleviated to ≤ 1 grade before entering the study, except hair loss;
- HIV antibody test results were negative at the time of screening;
- Patients with active hepatitis B virus (HBV) infection: HBV DNA < 2000 IU/mL obtained within 28 days before the start of study treatment, and at least 7 days of anti-HBV treatment (according to the local standard treatment, such as entecavir) before the study and willing to continue treatment during the study
- Women of childbearing age must have a negative pregnancy test (beta HCG) before starting treatment, women and men of reproductive age (having sex with women of reproductive age) must agree to use effective contraceptive measures during treatment and 6 months after the last dose of treatment.
Who cannot join
- History of soft meningitis;
- Current or previous 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's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with autoimmune hypothyroidism and receiving thyroid hormone replacement therapy were eligible to participate in the study; patients with controlled type 1 diabetes receiving insulin therapy were eligible to participate in the study; patients with eczema, psoriasis, chronic lichen simplex, or vitiligo with dermatologic clinical manifestations only (e.g., patients with psoriasis arthritis were excluded) were eligible to participate as long as all of the following conditions were met: 1. Rash area must be < 10% of body surface area; 2. The disease was well controlled at baseline and required only low-potency topical glucocorticoids. 3. In the past 12 months, the original condition did not appear to require psoralen plus A-band ultraviolet radiation, methotrexate, vitamin A acid, biological agents, oral calcineurin inhibitors or highly active or oral corticosteroids treatment of acute exacerbation;
- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchitis), drug pneumonia or idiopathic pneumonia or evidence of active pneumonia on screening chest computed tomography (CT) scan; A history of radiation pneumonitis in the area of allowable radiation (fibrosis);
- known active tuberculosis;
- Significant cardiovascular disease within 3 months before the start of study treatment (for example, New York Heart Association grade II or worse heart disease, myocardial infarction or cerebrovascular accident within 3 months before the start of study treatment), unstable arrhythmia or unstable angina;
- History of congenital long QT syndrome or corrected QT interval > 500 ms at screening (calculated using Fridericia method);
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- history of uncorrectable serum potassium, calcium or magnesium electrolyte disorders;
- Patients who have undergone major surgery (except diagnosis) within 4 weeks before the start of study treatment or are expected to undergo major surgery during the study period;
- Have had malignant tumors other than HCC within 5 years before screening, except for those with negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated in situ cervical cancer, non-melanoma skin cancer, localized prostate cancer, in situ cancer or stage I uterine cancer;
- Severe infection within 4 weeks before the start of study treatment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications;
- Oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to the start of study treatment; Patients receiving preventive antibiotics (e.g., prevention of urinary tract infections or chronic obstructive pulmonary disease exacerbations) were eligible to participate;
- Previous allogenic stem cell or solid organ transplantation;
- Patients who have received live attenuated vaccine treatment within 4 weeks before the start of study treatment, or are expected to receive such vaccine during the treatment period or 5 months after the last administration of altezumab;
- Untreated or incompletely treated patients with esophageal and/or gastric varices with bleeding or high risk of bleeding; Prior to enrollment, patients must undergo ultrasound, CT, MRI, or liver elasticity testing to assess the size of all varices (small to large) and be treated according to local standard of care. Patients who have had a corresponding examination within 6 months prior to starting study treatment do not need to repeat the examination;
- Coinfection with HBV and HCV. Patients with a history of HCV infection and a negative PCR result for HCV RNA were considered not infected with HCV;
- symptomatic, untreated or progressive central nervous system (CNS) metastases; Asymptomatic patients with treated CNS disease were eligible for the study if they met all of the following criteria: they had disease outside the CNS that could be measured according to RECIST v1.1; they had no history of intracranial hemorrhage or intraspinal hemorrhage; their metastatic disease was limited to the Cerebellar or supratentorial region (i.e., they had no midbrain, pontine, medullary, or spinal cord metastases); there was no evidence of progression between completing CNS-guided therapy and starting study treatment; the patients had not been treated with stereotactic, whole brain radiotherapy, and/or neurosurgical resection within 28 days prior to starting study treatment; and the patients did not have the need for ongoing glucocorticoid therapy for CNS disease. A stable dose of anticonvulsant therapy was allowed. Asymptomatic patients with newly detected CNS metastases at screening, after radiotherapy or surgery, were eligible to participate in the study without the need for repeat screening brain scans;
- patients can not accept follow-up or are participating in other liver cancer comprehensive treatment of the relevant clinical trials;
- The researchers believe that subjects who are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
Ti Zhang contact
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200062
Lu Wang, M.D., +86-18121299357, w.lr@hotmail.com
About this study
Official title: Efficacy and Safety of Multifocal Stereotactic Radiotherapy Combined With Atezolizumab and Bevacizumab in the Treatment of Metastatic Hepatocellular Carcinoma: An Open-label, Single-arm Exploratory Study
This is An Open-label, Single-arm Exploratory Study to determine the efficacy and safety of Multifocal Stereotactic Radiotherapy Combined with Atezolizumab and Bevacizumab in the Treatment of Metastatic Hepatocellular Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Multifocal Stereotactic Radiotherapy, Atezolizumab Injection [Tecentriq], Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifocal Stereotactic RadiotherapyRadiation
Radiotherapy will be given in combination with atezolizumab and bevacizumab. The patient will be initially treated with atezolizumab and bevacizumab after enrollment. Radiotherapy will be administered to the metastases 1-2 weeks after the completion of the first intravenous injection of atezolizumab and bevacizumab, in the mode of multifocal stereotactic radiotherapy, with a planned total dose to the planned target volume of 25-50 Gy in five divided doses of 5-10 Gy/fraction. Systemic therapy could be continued 48 hours after completion of radiotherapy.
Atezolizumab Injection [Tecentriq]Drug
Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
BevacizumabDrug
Bevacizumab will be administered by IV, 10 mg/kg on day 1 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| T+A+RAD | Experimental | Not described Receives: Radiation: Multifocal Stereotactic Radiotherapy; Drug: Atezolizumab Injection [Tecentriq]; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate, ORR
Percentage of Participants with Objective Response According To Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Duration of Objective Response (DoR)
time interval between objective response to progression
Measured: through study completion, an average of 1 year
Disease Control Rate (DCR)
CR+PR+SD
Measured: through study completion, an average of 1 year
Time to progression (TTP)
From screening to the first occurrence of disease progression from any cause up to end of study
Measured: through study completion
Progression-free survival (PFS)
From screening to the first occurrence of disease progression or death from any cause up to end of study
Measured: through study completion
Overall survival (OS)
From screening to death from any cause up to end of study
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start12 Jan 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (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 Fudan UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Lu Wang, MD, PhD, Fudan University
- Investigators
- Lu Wang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396937
- Sponsor's protocol ID
- TA-RAD
- Status last verified
- May 2022
- First submitted
- 2 Apr 2022
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Multifocal Stereotactic Radiotherapy Combined With Atezolizumab and Bevacizumab in the Treatment of Metastatic Hepatocellular Carcinoma: An Open-label, Single-arm Exploratory Study
- ClinicalTrials.gov ID
- NCT05396937
- Acronym / sponsor ID
- TA-RAD
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 May 2022 (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.
This is An Open-label, Single-arm Exploratory Study to determine the efficacy and safety of Multifocal Stereotactic Radiotherapy Combined with Atezolizumab and Bevacizumab in the Treatment of Metastatic Hepatocellular Carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T+A+RAD | Experimental | Radiation: Multifocal Stereotactic Radiotherapy, Drug: Atezolizumab Injection [Tecentriq], Drug: Bevacizumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or non-pregnant female between the ages of 18 and 70;
- signed informed consent;
- The researchers believe that patients have the ability to comply with the research program;
- hepatocellular carcinoma (HCC) by histological or cytological or clinical diagnosis;
- imaging examination confirmed extrahepatic dissemination, including at least one evaluable (according to the criteria of RECIST1.1) extrahepatic metastasis;
Key exclusion criteria (18 listed)
- History of soft meningitis;
- Current or previous 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's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with autoimmune hypothyroidism and receiving thyroid hormone replacement therapy were eligible to participate in the study; patients with controlled type 1 diabetes receiving insulin therapy were eligible to participate in the study; patients with eczema, psoriasis, chronic lichen simplex, or vitiligo with dermatologic clinical manifestations only (e.g., patients with psoriasis arthritis were excluded) were eligible to participate as long as all of the following conditions were met: 1. Rash area must be < 10% of body surface area; 2. The disease was well controlled at baseline and required only low-potency topical glucocorticoids. 3. In the past 12 months, the original condition did not appear to require psoralen plus A-band ultraviolet radiation, methotrexate, vitamin A acid, biological agents, oral calcineurin inhibitors or highly active or oral corticosteroids treatment of acute exacerbation;
- Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchitis), drug pneumonia or idiopathic pneumonia or evidence of active pneumonia on screening chest computed tomography (CT) scan; A history of radiation pneumonitis in the area of allowable radiation (fibrosis);
- known active tuberculosis;
- Significant cardiovascular disease within 3 months before the start of study treatment (for example, New York Heart Association grade II or worse heart disease, myocardial infarction or cerebrovascular accident within 3 months before the start of study treatment), unstable arrhythmia or unstable angina;
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 |
|---|---|---|
| Multifocal Stereotactic RadiotherapyRadiotherapy will be given in combination with atezolizumab and bevacizumab. The patient will be initially treated with atezolizumab and bevacizumab after enrollment. Radiotherapy will be administered to the metastases 1-2 weeks after the completion of the first intravenous injection of atezolizumab and bevacizumab, in the mode of multifocal stereotactic radiotherapy, with a planned total dose to the planned target volume of 25-50 Gy in five divided doses of 5-10 Gy/fraction. Systemic therapy could be continued 48 hours after completion of radiotherapy. | Radiation | T+A+RAD |
| Atezolizumab Injection [Tecentriq]Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle | Drug | T+A+RAD |
| BevacizumabBevacizumab will be administered by IV, 10 mg/kg on day 1 of each 21 day cycle | Drug | T+A+RAD |
Primary outcome
Objective response rate, ORR
Time frame: through study completion, an average of 1 year
Percentage of Participants with Objective Response According To Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
5 secondary outcomes
Duration of Objective Response (DoR)
Time frame: through study completion, an average of 1 year
Disease Control Rate (DCR)
Time frame: through study completion, an average of 1 year
Time to progression (TTP)
Time frame: through study completion
Progression-free survival (PFS)
Time frame: through study completion
Overall survival (OS)
Time frame: through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Individual participant dataSharing planned: No
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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.
Ti Zhang contact
Lu Wang principal investigator
Fudan University
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 Multifocal Stereotactic Radiotherapy, Atezolizumab Injection [Tecentriq] and Bevacizumab in people with Hepatocellular Carcinoma, run by Fudan University at 1 site in China.
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 16 inclusion and 18 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 31 May 2022. 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 China. 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 Lu Wang (+8615800680751, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate, ORR (time frame: through study completion, an average of 1 year). 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 31 May 2022.