Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
12 states
Healthy volunteers
No
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About this study
This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.
Sponsor: Academic and Community Cancer Research United
You may qualify if…
- ✓ Provide written informed consent =\< 28 days prior to randomization
- ✓ Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
- ✓ NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up
- ✓ Age \>= 18 years
- ✓ Hepatocellular carcinoma (HCC) confirmed by histological/cytological diagnosis or clinically per the American Association for the Study of Liver Diseases (AASLD) or WASL 2018 criteria
- ✓ Locally advanced, metastatic and/or unresectable disease that is not amendable to curative treatment
- ✓ Previously progressed on atezolizumab in combination with bevacizumab as first line systemic therapy for advanced disease
- ✓ NOTE: 2nd line patients only
You may not qualify if…
- ✕ Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma
- ✕ Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib)
- ✕ NOTE: Use of multi-kinase inhibitor(s) for adjuvant or as part of loco-regional therapies is allowed as long as the therapy was completed \>= 6 months prior to randomization
- ✕ Any of the following prior therapies:
- ✕ Major surgery =\< 4 weeks prior to randomization; Minor surgery =\< 7 days prior to randomization (e.g., simple excision, tooth extraction, insertion of central lines/Mediport). Subjects with clinically relevant complications from prior surgery are not eligible
- ✕ Any anti-cancer agent =\< 2 weeks prior to randomization
- ✕ Radiation therapy =\< 4 weeks (1 week for palliative radiation for bone metastases and/or for pain control) or radionuclide treatment (e.g., I-131 or Y-90) =\< 6 weeks prior to randomization
- ✕ Treatment with investigational therapy =\< 28 days prior to randomization
Where it's recruiting
Scottsdale
Jacksonville · Weston
Chicago · Urbana
New Orleans
Ann Arbor
Rochester
Buffalo
Durham
Cleveland
Pittsburgh
Rapid City
Milwaukee
Source: ClinicalTrials.gov · NCT05168163 · last updated 2025-09-16