Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived from Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Atezolizumab; Drug: Bevacizumab; Drug: UCPVax

• Registration Number: NCT05528952
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-01
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Study Start: 2022-09-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-04-27
• Study Completion: 2029-09-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm (Arm B)	Bevacizumab	Atezoliumab + Bevacizumab
Experimental Arm (Arm A)	Atezolizumab	Atezolizumab + Bevacizumab + UCPVax
Experimental Arm (Arm A)	Bevacizumab	Atezolizumab + Bevacizumab + UCPVax
Control Arm (Arm B)	Atezolizumab	Atezoliumab + Bevacizumab
Experimental Arm (Arm A)	UCPVax	Atezolizumab + Bevacizumab + UCPVax

Primary Outcome Measures

Name	Time	Method
objective response rate (ORR)	at 6 months	addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria

Secondary Outcome Measures

Name	Time	Method
progression-free-survival (PFS)	through study completion, an average of 2 years	delay from the date of randomization to the disease progression or death from any cause whichever occurs first
disease control rate (DCR)	at 6 months	addition of complete response (CR), partial response (PR), and stable disease (SD) rates, evaluated by RECIST criteria v1.1 and imRECIST
overall survival (OS)	through study completion, an average of 2 years	delay from the date of randomization to death from any cause.

Trial Locations

Locations (12)

CH William Morey; 🇫🇷 Chalon-sur-Saône, France

CH de Mulhouse; 🇫🇷 Mulhouse, France

CHU de Besançon; 🇫🇷 Besançon, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Centre Georges François Leclerc; 🇫🇷 Dijon, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Centre Hospitalier Paris St Joseph; 🇫🇷 Paris, France

Groupe Hospitalier Paris Salpetrière; 🇫🇷 Paris, France

Hôpital BEAUJON; 🇫🇷 Paris, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Hôpital Paul Brousse; 🇫🇷 Villejuif, France