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NCT05168163
Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer
Phase 2 trial testing Atezolizumab in Locally Advanced Hepatocellular Carcinoma in 122 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Academic and Community Cancer Research United |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 122 |
| Start date | 27 May 2022 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2026 |
| Sites | 16 locations across United States |
Drugs / interventions tested
- Atezolizumab (atezolizumab) — full drug profile →
- Cabozantinib (CABOZANTINIB) — full drug profile →
- Lenvatinib (LENVATINIB) — full drug profile →
Conditions studied
- Locally Advanced Hepatocellular Carcinoma — all drugs for Locally Advanced Hepatocellular Carcinoma →
- Metastatic Hepatocellular Carcinoma — all drugs for Metastatic Hepatocellular Carcinoma →
- Stage III Hepatocellular Carcinoma AJCC v8 — all drugs for Stage III Hepatocellular Carcinoma AJCC v8 →
- Stage IIIA Hepatocellular Carcinoma AJCC v8 — all drugs for Stage IIIA Hepatocellular Carcinoma AJCC v8 →
Sponsor
Academic and Community Cancer Research United — full company profile →
Who can join
18 and older, any sex, with Locally Advanced Hepatocellular Carcinoma or Metastatic Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Biomarkers for diagnosis and therapeutic options in hepatocellular carcinoma.
Chan YT, Zhang C, Wu J, Lu P, et al · · 2024 · cited 158× · PMID 39242496 · DOI 10.1186/s12943-024-02101-z -
Immunosuppressive tumor microenvironment modulation by chemotherapies and targeted therapies to enhance immunotherapy effectiveness.
Barnestein R, Galland L, Kalfeist L, Ghiringhelli F, et al · · 2022 · cited 66× · PMID 36117524 · DOI 10.1080/2162402x.2022.2120676 -
The New Era of Systemic Treatment for Hepatocellular Carcinoma: From the First Line to the Optimal Sequence.
Cerreto M, Cardone F, Cerrito L, Stella L, et al · · 2023 · cited 26× · PMID 37887533 · DOI 10.3390/curroncol30100633 -
Immunotherapy in liver cancer: overcoming the tolerogenic liver microenvironment.
Liu Y, Yang H, Li T, Zhang N. · · 2024 · cited 23× · PMID 39295859 · DOI 10.3389/fimmu.2024.1460282 -
Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898 -
Immunotherapy in hepatocellular carcinoma: how will it reshape treatment sequencing?
Cammarota A, Zanuso V, Manfredi GF, Murphy R, et al · · 2023 · cited 17× · PMID 36643654 · DOI 10.1177/17588359221148029 -
Real-World Study of Systemic Treatment after First-Line Atezolizumab plus Bevacizumab for Hepatocellular Carcinoma in Asia-Pacific Countries.
Lee CK, Yoo C, Hong JY, Park SJ, et al · · 2025 · cited 15× · PMID 40255875 · DOI 10.1159/000540969 -
c-MET and the immunological landscape of cancer: novel therapeutic strategies for enhanced anti-tumor immunity.
Jabbarzadeh Kaboli P, Roozitalab G, Farghadani R, Eskandarian Z, et al · · 2024 · cited 12× · PMID 39664377 · DOI 10.3389/fimmu.2024.1498391
Verify or expand the search:
- PubMed search for NCT05168163
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Locally Advanced Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
- NCT06873269 — Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma · recruiting
- NCT05705492 — Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancre · Phase 2 · recruiting
- NCT05377034 — Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab P · Phase 2 · recruiting
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Other Academic and Community Cancer Research United trials
Trials by the same sponsor.
- NCT06160206 — Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma · Phase 2 · recruiting
- NCT06238648 — Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission After CD19-directed · Phase 2 · recruiting
- NCT05910801 — Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma · Phase 2 · recruiting
- NCT05356897 — Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molec · Phase 2 · withdrawn
- NCT05194293 — Regorafenib and Durvalumab for the Treatment of High-Risk Liver Cancer · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05168163 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Academic and Community Cancer Research United
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05168163.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing