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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.

Phase 2RecruitingAcademic and Community Cancer Research UnitedNCT05168163Data as of May 2026

Treatment: Atezolizumab · Cabozantinib · LenvatinibThis 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.

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Extracted 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

Min 1 prior line

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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