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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Comparison of SBRT and SIRT With Combination IO for Locally-advanced, Unresectable HCCs (BIIRTH)
ClinicalTrials.gov ID: NCT07293468
What this study is testing
What is Atezolizumab & Bevacizumab?
Atezolizumab & Bevacizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to compare the safety and efficacy of sequential Transarterial Chemoembolization (TACE) and Stereotactic body radiation therapy (SBRT) versus Y90-radioembolisation (SIRT), followed by systemic therapy in patients with large, locally advanced, unresectable Hepatocellular carcinoma (HCC). The main question it aims to answer is whether Sequential TACE-SBRT potentially gives longer Progression-free survival (PFS) benefit with similar toxicities as compared with Y90 SIRT.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patients diagnosed with HCC either by histology or by the American Association for the Study of Liver Diseases Criteria (AASLD) 2018
- Patients age 18-80 years of age with HCCs deemed unresectable at the Multidisciplinary Team Meetings (MDTs) because of the following:
- R0 resection not feasible e.g. unfavourable tumour location
- Remnant liver volume \<30% in non-cirrhotic patients or 40% in cirrhotic patients
- Indocyanine green test \>15%
You likely can't join if
- Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer...
- Presence of any extra-hepatic metastases
- Presence of main portal vein (PV) or inferior vena cava (IVC) involvement
- Presence of active, uncontrolled varices
- Presence of active, severe comorbidities including uncontrolled cardiovascular or cerebrovascular diseases or recent events within 6months prior to...
- Received prior non-curative locoregional (including TACE, RT to liver, SIRT) or systemic therapy received for HCC\\
See the full eligibility criteria
- Patients diagnosed with HCC either by histology or by the American Association for the Study of Liver Diseases Criteria (AASLD) 2018
- Patients age 18-80 years of age with HCCs deemed unresectable at the Multidisciplinary Team Meetings (MDTs) because of the following:
- R0 resection not feasible e.g. unfavourable tumour location
- Remnant liver volume \<30% in non-cirrhotic patients or 40% in cirrhotic patients
- Indocyanine green test \>15%
- Patients with Barcelona Clinic Liver Cancer (BCLC) stage B2-4 (unresectable group) or C
- Tumour sizes of ≥5cm, of which ≥1 is a measurable lesion as defined by the mRECIST criteria
- people aged 18-80 years of age
- ECOG performance status of 0-1
- Predicted life expectancy should be of ≥ 3 months
- Child Pugh (CP) score of A5-B7
- Adequate organ and marrow functions, as listed below:
- Haemoglobin ≥9 g/dL
- Absolute neutrophil count ≥1,500/uL
- Platelet count ≥100,000/L
- Total bilirubin ≤2.0 x upper limit of normal (ULN)
- Albumin ≥2.8 g/dL
- ALT ≤3 x ULN
- INR ≤1.6
- Calculated creatinine clearance (eGFR) ≥45 mL/minute as determined by Cockcroft-Gault (using actual body weight) or 24-hour urine creatinine clearance
- Liver volume minus intrahepatic gross tumour volume (GTV) with \>700cc
- Patients with concomitant HBV infection (defined as having HBsAg positive and/or detectable HBV DNA level) must be treated with antiviral therapy (per local institutional practice) to ensure adequate viral suppression...
- Informed consent provided
- Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
- Females of childbearing potential must have negative serum or urine pregnancy test
- Prior invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, lobular or ductal carcinoma in situ of...
- Presence of any extra-hepatic metastases
- Presence of main portal vein (PV) or inferior vena cava (IVC) involvement
- Presence of active, uncontrolled varices
- Presence of active, severe comorbidities including uncontrolled cardiovascular or cerebrovascular diseases or recent events within 6months prior to treatment
- Received prior non-curative locoregional (including TACE, RT to liver, SIRT) or systemic therapy received for HCC\\
- Prior treatment with any anti-programmed cell death protein-1 (anti-PD-1), PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent, or an antibody targeting other immune-regulatory receptor(s) or mechanism(s)
- Use of chronic systemic steroid or any other immunosuppressive medication within 14days prior to treatment initiation, except:
- Intranasal, inhaled, topical steroids, or local steroid injection;
- Systemic corticosteroids at physiologic doses ≤10mg/day of prednisone or equivalent;
- Steroids as premedication for hypersensitivity reactions
- Active or documented autoimmune or inflammatory disorders within 2years, except diabetes type I, vitiligo, psoriasis, or hypo-/hyperthyroid diseases not requiring immunosuppressant(s)
- Known history of a positive HIV test, primary/acquired immunodeficiency syndrome, or solid organ transplantation
- Receipt of live, attenuated vaccine within 28 days prior to study treatment
- Severe hypersensitivity reaction to another monoclonal antibody
- Presence of any contraindication to TACE not otherwise listed: cisplatin allergy
- Presence of any contraindication to SBRT not otherwise listed:
- Maximal size of any one HCC \>25 cm
- Direct tumour extension into gastrointestinal structures (stomach, duodenum, remaining small or large bowel)
- Presence of any contraindication to SIRT not otherwise listed:
- Pre-treatment 99mTc-MAA scan \>20% lung shunting of hepatic artery blood flow, or a demonstration of radiation exposure to the lungs potentially \>25Gy
- Pre-treatment hepatic angiogram showing potential Y90 microspheres deposition in the gastrointestinal tract or any other organ(s) which is not correctable by catheter embolization techniques.
- Pregnant or lactating females
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.