The TERTIO trial will propose to determine the clinical interest and immunological efficacy of a treatment combining the CD4 helper T-inducer cancer anti-telomerase vaccine (UCPVax) with anti-PD-L1 therapy (atezolizumab) and bevacizumab in unresectable HCC by evaluation of the objective response rate at 6 months (randomized phase II, 10 centers, 105 patients)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
CHU de Besançon
Besançon, France
RECRUITINGCH William Morey
Chalon-sur-Saône, France
RECRUITINGHôpital Henri Mondor
Créteil, France
RECRUITINGCentre Georges François Leclerc
Dijon, France
RECRUITINGHôpital Nord Franche-Comté
Montbéliard, France
RECRUITINGCHU de Montpellier
Montpellier, France
RECRUITINGCH de Mulhouse
Mulhouse, France
RECRUITINGInstitut de Cancérologie de l'Ouest
Nantes, France
NOT_YET_RECRUITINGCentre Hospitalier Paris St Joseph
Paris, France
NOT_YET_RECRUITINGGroupe Hospitalier Paris Salpetrière
Paris, France
RECRUITING...and 4 more locations
objective response rate (ORR)
addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria
Time frame: at 6 months
overall survival (OS)
delay from the date of randomization to death from any cause.
Time frame: through study completion, an average of 2 years
progression-free-survival (PFS)
delay from the date of randomization to the disease progression or death from any cause whichever occurs first
Time frame: through study completion, an average of 2 years
disease control rate (DCR)
addition of complete response (CR), partial response (PR), and stable disease (SD) rates, evaluated by RECIST criteria v1.1 and imRECIST
Time frame: at 6 months
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