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Neoadjuvant Atezo, Adjuvant Atezo + Beva Combined With RF Ablation of Small HCC: a Multicenter Randomized Phase II Trial

Study acronym: AB-LATE02
StatusActive, Not Recruiting
PhasePhase 2
Started2021-02-23
View on ClinicalTrials.gov ↗

Amendment history

2026-06-17
Recruiting→Active, Not Recruiting Study Status, Oversight, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 19 of 19 sites
2025-09-24
Study Identification, Study Status, Oversight v16
Primary completion date2026-02→2028-02
Start date2021-01-26→2021-02-23
2024-07-25
Study Status v15
Primary completion date2025-01→2026-02
Completion date2027-07→2031-02
2023-08-01
Study Status v14
Re-verified, no change to tracked fields
2022-07-16
Study Status, Eligibility, Contacts/Locations v13
Eligibility criteria+42 characters
Inclusion Criteria: Male or female patients ≥ 18 years of age Diagnostic of HCC based on histologyImaging (EASL guidelines) Patients with HCC eligible for ablation as assessed by mult [...] HCC and cholangiocarcinoma, namely hepatocholangiocarcinoma), if a biopsy is available Current or recent (≤ 10 days prior to initiation of study t [...]
Study sitesdetails revised at 3 of 19 sites
Show 12 earlier versions
2021-12-22
Study Status, Study Description, Contacts/Locations v12
Study sites18→19
Study description-36 characters
[...] addition of the biotherapy (i.e. in the Experimental arm). The total duration of the project is scheduled for 2 years, plus a 3-year follow-up. The patients' recruitment timeframe is set at 1836 months and the patient's follow-up timeframe is 5 years. 202 patients are to be included, 101 per arm.
2021-11-17
Study Status, Contacts/Locations v11
Study sites16→18
2021-07-02
Study Status, Contacts/Locations v10
Study sitesdetails revised at 2 of 16 sites
2021-06-24
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 16 sites
2021-06-21
Study Status, Contacts/Locations v8
Study sitesdetails revised at 1 of 16 sites
2021-06-11
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 16 sites
2021-05-28
Study Status, Eligibility, Contacts/Locations v6
Study sites13→16
Eligibility criteria+2,652 characters
[...] CC and cholangiocarcinoma, namely hepatocholangiocarcinoma) TreatmentCurrent or recent (≤ 10 days prior to initiation of study treatment) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purpose. Prophylactic anticoagulation for the patency of venous access devices is allowed provided the activity [...] with anticoagulantsclopidogrel, (heparindipyramidole, ticlopidine, or AVK)cilostazol. Active thator cannothistory beof interruptedautoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, [...] [...]
2021-05-05
Study Status, Study Description v5
Study description+45 characters
[...] suggest that the combined vascular endothelial growth factor (VEGF) / Programmed death-ligand 1 (VEGF/PD-L1) blockade may be clinically beneficial in a number of [...] st Atezolizumab + Bevacizumab in combination with ablation. WeThe investigators hypothesized that the combo of Atezolizumab + Bevacizumab a [...] s adjuvants, should theoretically, and hopefully, limit the radiofrequency ablation (RFA) pro-tumor effects. The RFS current rate value of 45% corres [...]
2021-04-29
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v4
Eligibility criteria+33 characters
[...] t pathways (including those targeting PD-1, PD-L1 or PD-L2, cluster of differentiation 137 (CD137), or cytotoxic T-lymphocyte antigen [(CTLA-4])). Patients with uncontrolled HBV infection and viral load a [...]
Study description+2,650 characters
Liver cancer is the sixth most common cancer and the third leading cause of death from cancer worldwide (source: Globocan 2018). Hepatocellular carcinoma (HCC) represents 80-90% of liver cancers. Percutaneous thermal ablation (PTA) is a validated treatment option for very early and early stage HCC, [...]
Study sitesdetails revised at 3 of 13 sites
Study title+19 characters
Neoadjuvant Atezolizumab andAtezo, Adjuvant AtezolizumabAtezo + BevacizumabBeva in CombinationCombined With RFARF Ablation of Small HCC: a Multicenter Randomized Phase II Trial
2021-04-09
Study Status, Contacts/Locations v3
Study sitesdetails revised at 2 of 13 sites
2021-02-03
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v2
InterventionsAtezolizumab (Drug), Atezolizumab (Drug), Bevacizumab (Drug), Percutaneous Radiofrequency (Procedure)→Atezolizumab (adjuvant) (Drug), Atezolizumab (neoadjuvant) (Drug), Bevacizumab (adjuvant) (Drug), Percutaneous Radiofrequency (Procedure)
Study title-33 characters
NEOADJUVANTNeoadjuvant ATEZOLIZUMABAtezolizumab ANDand ADJUVANTAdjuvant ATEZOLIZUMABAtezolizumab + BEVACIZUMABBevacizumab INin COMBINATIONCombination WITHWith PERCUTANEOUSRFA RADIOFREQUENCYof ABLATION OF SMALLSmall HCC
2021-01-28
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-01→confirmed 2021-01-26
Study sitesdetails revised at 13 of 13 sites
2021-01-22
Original filing
Following the results of study IMbrave150, the combination Atezolizumab + Bevacizumab is a promising treatment option for patients with HCC. In addition, the high intrahepatic distant recurrence rate and accumulating evidence for a metastatic mechanism encourages exploring adjuvant/neoadjuvant strategies targeting tumor growth and metastatic escape in the context of percutaneous thermal ablation for small HCC. Local ablation of HCC is therefore an "ideal" setting for testing atezolizumab + bevacizumab in combination with ablation, with the aim of reducing the risk of recurrence.
Trial Details
NCT Number NCT04727307
Lead Sponsor University Hospital, Montpellier
Conditions Hepatocellular Carcinoma
Enrollment 202 participants
Start Date 2021-02-23
Primary Completion 2028-02 (estimated)
Study Completion 2031-02 (estimated)
Updated on ClinicalTrials.gov 2026-06-22