NCT05168163 Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
| NCT ID | NCT05168163 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Academic and Community Cancer Research United |
| Condition | Locally Advanced Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2022-05-27 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Child Pugh class A * Documented virology status of hepatitis, as confirmed by sc
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