Hepatocellular CarcinomaPhase 2TERTIONCT05528952
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
A Phase 2 study testing Atezolizumab, Bevacizumab and UCPVax in people with Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 14 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Atezolizumab, Bevacizumab and UCPVax
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 14 sitesFrance
- Study dates
- 27 Sep 2022to 27 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main inclusion Criteria:
- Signed informed consent
- Histologically confirmed hepatocellular carcinoma
- Locally advanced, metastatic, or unresectable disease
- Patient who had not previously received systemic anti-cancer treatment
- Age ≥ 18 years
- 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.)
- 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
- Performance status < 2
- Child-Pugh Class A status
- BCLC C stage or BCLC B stage not eligible to loco-regional therapy according to the Barcelona Clinic Liver Cancer (BCLC) staging system
Main exclusion Criteria:
Non-eligible to a clinical trial:
- Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
- 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
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Current participation in a study of an investigational agent or in the period of exclusion
- Patient under guardianship, curatorship or under the protection of justice Cancer-specific exclusion criteria:
- Know fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
- 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
- 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:
- History of encephalopathy
- Prior bleeding event due to untreated or incompletely treated esophageal and/or gastric varices within 6 months prior to randomization
- Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Angélique VIENOT, Dr contact
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
CHU de Besançon
Besançon
Christophe BORG, Pr
- Recruiting
CH William Morey
Chalon-sur-Saône
Pierre Verdier-Davioud, Dr
- Recruiting
Hôpital Henri Mondor
Créteil
Hélène REGNAULT, Dr
- Recruiting
Centre Georges François Leclerc
Dijon
François GHIRINGHELLI, Pr
- Recruiting
Hôpital Nord Franche-Comté
Montbéliard
Serge FRATTE, Dr
- Recruiting
CHU de Montpellier
Montpellier
Eric ASSENAT, Pr
- Recruiting
CH de Mulhouse
Mulhouse
Stephanie HUSSON-WETZEL, Dr
- Not yet recruiting
Institut de Cancérologie de l'Ouest
Nantes
Amélie MALLET, Dr
- Not yet recruiting
Centre Hospitalier Paris St Joseph
Paris
Eric RAYMOND, Pr
- Recruiting
Groupe Hospitalier Paris Salpetrière
Paris
Manon ALLAIRE, Dr
- Recruiting
Hôpital BEAUJON
Paris
Mohamed BOUATTOUR, Dr
- Recruiting
Institut Mutualiste Montsouris
Paris
Emilie SOULARUE, Dr
- Not yet recruiting
CHU de Poitiers
Poitiers
Valentin ROLLE, Dr
- Recruiting
Hôpital Paul Brousse
Villejuif
Pascal HAMMEL, Dr
Olivier ROSMORDUC, Dr
About this study
Official title: Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)
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)
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Atezolizumab, Bevacizumab, UCPVax
- Keywords
- CD4 Th1-inducer cancer vaccine
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
BevacizumabDrug
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
UCPVaxDrug
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm (Arm A) | Experimental | Atezolizumab + Bevacizumab + UCPVax Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: UCPVax |
| Control Arm (Arm B) | Other | Atezoliumab + Bevacizumab Receives: Drug: Atezolizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate (ORR)
addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria
Measured: at 6 months
Secondary outcomes (3)
overall survival (OS)
delay from the date of randomization to death from any cause.
Measured: 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
Measured: 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
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start27 Sep 2022
- Primary completion27 Mar 2028 (estimated)
- Study completion27 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group, PRODIGE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528952
- Sponsor's protocol ID
- 2022/680
- Acronym
- TERTIO
- Status last verified
- Mar 2026
- First submitted
- 1 Sep 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37516867
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma: a Proof of Concept Randomized Phase II Study (TERTIO - Prodige 82)
- ClinicalTrials.gov ID
- NCT05528952
- Acronym / sponsor ID
- TERTIO / 2022/680
- Conditions
- Hepatocellular Carcinoma
- Keywords
- CD4 Th1-inducer cancer vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- GERCOR - Multidisciplinary Oncology Cooperative Group, PRODIGE
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 27 Mar 2028 (estimated)
- Study completion
- 27 Feb 2030 (estimated)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm (Arm A) | Experimental | Drug: Atezolizumab, Drug: Bevacizumab, Drug: UCPVaxAtezolizumab + Bevacizumab + UCPVax |
| Control Arm (Arm B) | Other | Drug: Atezolizumab, Drug: BevacizumabAtezoliumab + Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atezolizumab1200 mg IV every 3 weeks until disease progression or unacceptable toxicity | Drug | Control Arm (Arm B), Experimental Arm (Arm A) |
| Bevacizumab15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity | Drug | Control Arm (Arm B), Experimental Arm (Arm A) |
| UCPVaxUCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously | Drug | Experimental Arm (Arm A) |
Primary outcome
objective response rate (ORR)
Time frame: at 6 months
addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria
3 secondary outcomes
overall survival (OS)
Time frame: through study completion, an average of 2 years
progression-free-survival (PFS)
Time frame: through study completion, an average of 2 years
disease control rate (DCR)
Time frame: at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 37516867Vienot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angélique VIENOT, Dr contact
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atezolizumab, Bevacizumab and UCPVax in people with Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Borg Christophe, Pr (+33 3 81 47 99 99, xtoph.borg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (ORR) (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05528952, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.