Atezolizumab+Bevacizumab+SBRT in Unresectable HCC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
This research study is evaluating the safety and tolerability of the drugs atezolizumab and bevacizumab with stereotactic body radiation therapy (SBRT) for treating unresectable hepatocellular carcinoma.
This study involves the following interventions:
* Atezolizumab * Bevacizumab * Stereotactic body radiation therapy (SBRT)
Eligibility criteria
Qualifiers
Histologically or cytologically proven diagnosis of HCC within 180 days prior to study registration.
At least 1 solid liver lesion or vascular tumor thrombus (involving portal vein, IVC, and/or hepatic vein) > 1 cm with arterial enhancement and delayed washout on multiphasic CT or MRI. Radiologic imaging evaluation must occur within 28 days prior to study registration.
Enhancing vascular thrombosis demonstrating arterial enhancement and delayed washout of multiphasic MRI. Radiologic imaging evaluation must occur within 30 days prior to study registration.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm (≥2 cm) by chest x-ray or as ≥10 mm (≥1 cm) with CT scan, MRI, or calipers by clinical exam. See Section 12 (Measurement of Effect) for the evaluation of measurable disease.
Disqualifiers
Prior systemic therapy
Prior radiation to the region of the liver that would result in excessive doses to normal tissues due to overlap of RT fields is not allowed. Radiotherapy within 28 days and abdominal/pelvic radiotherapy within 60 days prior to initiation of study treatment are not allowed. Exception for palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment.
Prior selective internal radiotherapy (SIRT) or hepatic arterial Yttrium therapy, at any time.
Direct tumor extension into the stomach, duodenum, small bowel, or large bowel.
Trial design
Treatments tested in this trial
- Atezolizumab
- Bevacizumab
- Stereotactic body radiation therapy (SBRT)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov