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Atezolizumab+Bevacizumab+SBRT in Unresectable HCC

ConditionUnresectable Hepatocellular Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Atezolizumab

    Drug

    Intravenous Infusion

  • Bevacizumab

    Drug

    Intravenous Infusion

  • Stereotactic body radiation therapy (SBRT)

    Radiation

    External Beam Radiation

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Stereotactic beam radiation therapy (SBRT) +Atezolizumab + BevacizumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity Rate

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
18 weeks

Secondary outcomes

1

Progression free survival (PFS)

Assessed per HCC mRECIST, imRECIST, and RECIST v1.1

Time frame
5 years
2

Overall Survival (OS)

Estimated using the Kaplan-Meier method

Time frame
5 years
3

In-field response rate

Assessed per RECIST v1.1, imRECIST, and HCC mRECIST

Time frame
5 years
4

Change in Child-Pugh Score

Analyzed as repeated measures using mixed models to characterize the trend over time. Child-Pugh scores range from 5 to 15, with higher scores indicating worse outcomes.

Time frame
2.5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Massachusetts General Hospital

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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