Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
NCT ID: NCT05528952
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
105 participants
INTERVENTIONAL
2022-09-27
2030-02-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Atezolizumab-bevacizumab and Other Immunotherapies: Real-life Experience for Treatment of Hepatocellular Carcinoma
NCT06806579
A Study of Participants With Initially Unresectable Hepatocellular Carcinoma That is Treated With Atezolizumab and Bevacizumab Plus Transarterial Chemoembolization
NCT06503250
FusionVAC22_01: Fusion Transcript-based Peptide Vaccine Combined with Immune Checkpoint Inhibition
NCT05937295
Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo
NCT07239245
WGc-0201 Plus Tislelizumab in HCC With High Risk of Recurrence and Metastasis After Radical Therapy
NCT07077369
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Arm (Arm A)
Atezolizumab + Bevacizumab + UCPVax
Atezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
Bevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
UCPVax
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
Control Arm (Arm B)
Atezoliumab + Bevacizumab
Atezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
Bevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Atezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
Bevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
UCPVax
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Histologically confirmed hepatocellular carcinoma
3. Locally advanced, metastatic, or unresectable disease
4. Patient who had not previously received systemic anti-cancer treatment
5. Age ≥ 18 years
6. Measurable disease defined according to mRECIST guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
7. Patients who have received previous chemoembolization, radioembolization and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 (according to National Cancer Institute \[NCI\] common terminology criteria for adverse events, version 5 (CTCAE v5) with the exception of Grade 2 alopecia
8. Performance status \< 2
9. Child-Pugh Class A status
10. BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system
Exclusion Criteria
1. Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
2. Diagnosis of additional malignancy within 3 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
3. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
4. Current participation in a study of an investigational agent or in the period of exclusion
5. Patient under guardianship, curatorship or under the protection of justice
6. Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
7. Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
8. Uncontrolled tumor-related pain: exposing patients to risk of exposure to corticoids or iterative hospitalizations. Symptomatic lesions amenable to palliative radiotherapy should be treated prior to inclusion. Patients should be recovered from the effects of radiation. There is no required minimum recovery period
9. Known active central nervous system metastases and/or carcinomatous meningitis. Subject with previously treated brain metastases and with radiological and clinical stability are allowed
Non-eligible to treatment:
10. History of encephalopathy
11. Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
12. Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
PRODIGE
UNKNOWN
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Besançon
Besançon, , France
CH William Morey
Chalon-sur-Saône, , France
Hôpital Henri Mondor
Créteil, , France
Centre Georges François Leclerc
Dijon, , France
Hôpital Nord Franche-Comté
Montbéliard, , France
CHU de Montpellier
Montpellier, , France
CH de Mulhouse
Mulhouse, , France
Institut de Cancérologie de l'Ouest
Nantes, , France
Centre Hospitalier Paris St Joseph
Paris, , France
Groupe Hospitalier Paris Salpetrière
Paris, , France
Hôpital BEAUJON
Paris, , France
Institut Mutualiste Montsouris
Paris, , France
CHU de Poitiers
Poitiers, , France
Hôpital Paul Brousse
Villejuif, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Christophe BORG, Pr
Role: primary
Pierre Verdier-Davioud, Dr
Role: primary
Hélène REGNAULT, Dr
Role: primary
François GHIRINGHELLI, Pr
Role: primary
Serge FRATTE, Dr
Role: primary
Eric ASSENAT, Pr
Role: primary
Stephanie HUSSON-WETZEL, Dr
Role: primary
Amélie MALLET, Dr
Role: primary
Eric RAYMOND, Pr
Role: primary
Manon ALLAIRE, Dr
Role: primary
Mohamed BOUATTOUR, Dr
Role: primary
Emilie SOULARUE, Dr
Role: primary
Valentin ROLLE, Dr
Role: primary
Pascal HAMMEL, Dr
Role: primary
Olivier ROSMORDUC, Dr
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Vienot A, Jacquin M, Rebucci-Peixoto M, Pureur D, Ghiringhelli F, Assenat E, Hammel P, Rosmorduc O, Stouvenot M, Allaire M, Bouattour M, Regnault H, Fratte S, Raymond E, Soularue E, Husson-Wetzel S, Di Martino V, Muller A, Clairet AL, Fagnoni-Legat C, Adotevi O, Meurisse A, Vernerey D, Borg C. Evaluation of the interest to combine a CD4 Th1-inducer cancer vaccine derived from telomerase and atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma: a randomized non-comparative phase II study (TERTIO - PRODIGE 82). BMC Cancer. 2023 Jul 29;23(1):710. doi: 10.1186/s12885-023-11065-0.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022/680
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.