OncoMatch/Clinical Trials/NCT05168163
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
Is NCT05168163 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Atezolizumab and Cabozantinib for locally advanced hepatocellular carcinoma.
Treatment: Atezolizumab · Cabozantinib · Lenvatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage III, IV, STAGE III AJCC V8, STAGE IIIA AJCC V8, STAGE IIIB AJCC V8, STAGE IV AJCC V8, STAGE IVA AJCC V8, STAGE IVB AJCC V8 (AJCC v8)
Locally advanced, metastatic and/or unresectable disease that is not amendable to curative treatment
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-L1 therapy in combination with anti-VEGF therapy (atezolizumab, bevacizumab) — first line systemic therapy for advanced disease
Previously progressed on atezolizumab in combination with bevacizumab as first line systemic therapy for advanced disease
Cannot have received: multi-kinase inhibitor (cabozantinib, lenvatinib, sorafenib, regorafenib)
Exception: Use for adjuvant or loco-regional therapies allowed if completed ≥ 6 months prior to randomization
Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib)
Cannot have received: major surgery
Major surgery ≤ 4 weeks prior to randomization
Cannot have received: minor surgery
Minor surgery ≤ 7 days prior to randomization
Cannot have received: anti-cancer agent
Any anti-cancer agent ≤ 2 weeks prior to randomization
Cannot have received: radiation therapy
Exception: 1 week for palliative radiation for bone metastases and/or for pain control
Radiation therapy ≤ 4 weeks (1 week for palliative radiation for bone metastases and/or for pain control)
Cannot have received: radionuclide treatment (I-131, Y-90)
radionuclide treatment (e.g., I-131 or Y-90) ≤ 6 weeks prior to randomization
Cannot have received: investigational therapy
Treatment with investigational therapy ≤ 28 days prior to randomization
Cannot have received: CD137 agonist
Prior treatment with CD137 agonists
Cannot have received: immune checkpoint blockade therapies (anti-CTLA-4, anti-PD-1, anti-PD-L1)
Exception: Prior treatment with atezolizumab is permitted
Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L (1500/uL) without G-CSF; lymphocyte count ≥ 0.5 x 10^9/L (500/uL); platelet count ≥ 75 x 10^9/L (75,000/uL); hemoglobin ≥ 90 g/L (9 g/dL)
Kidney function
Serum creatinine ≤ 2 x ULN or creatinine clearance ≥ 30 mL/min (Cockcroft-Gault)
Liver function
AST, ALT, ALP ≤ 5 x ULN; total bilirubin ≤ 3 x ULN; serum albumin ≥ 30 g/L (3.0 g/dL)
AST, ALT, ALP ≤ 5 x ULN; total bilirubin ≤ 3 x ULN; serum albumin ≥ 30 g/L (3.0 g/dL); Serum creatinine ≤ 2 x ULN or creatinine clearance ≥ 30 mL/min; ANC ≥ 1.5 x 10^9/L (1500/uL) without G-CSF; lymphocyte count ≥ 0.5 x 10^9/L (500/uL); platelet count ≥ 75 x 10^9/L (75,000/uL); hemoglobin ≥ 90 g/L (9 g/dL)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Arizona · Scottsdale, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Cleveland Clinic Weston Florida · Weston, Florida
- University of Chicago Comprehensive Cancer Center · Chicago, Illinois
- Carle Cancer Center NCI Community Oncology Research Program · Urbana, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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