Actively Recruiting
Evaluation of the Interest to Combine a CD4 Th1-inducer Cancer Vaccine Derived From Telomerase and Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma
Led by Centre Hospitalier Universitaire de Besancon · Updated on 2026-03-16
105
Participants Needed
14
Research Sites
387 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire de Besancon
Lead Sponsor
G
GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Histologically confirmed hepatocellular carcinoma
- Locally advanced, metastatic, or unresectable disease
- No prior systemic anti-cancer treatment
- Age 18 years or older
- Measurable disease by mRECIST guidelines
- Recovery to grade 1 or less toxicity from previous chemoembolization, radioembolization, or radiotherapy (except grade 2 alopecia)
- Performance status less than 2
- Child-Pugh Class A liver function
- BCLC C stage or BCLC B stage not eligible for loco-regional therapy
You will not qualify if you...
- Previous treatment with anti-PD-1, anti-PD-L1, anti-CTLA4 agents, or other immune therapies
- Diagnosis of another malignancy within past 3 years (except treated basal cell carcinoma or resected in situ cervical or breast cancer)
- Any medical or psychiatric condition making study participation inappropriate
- Current participation in another investigational study or within exclusion period
- Under legal guardianship, curatorship, or protection of justice
- Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Uncontrolled pleural effusion, pericardial effusion, ascites, or symptomatic fistula
- Uncontrolled tumor-related pain requiring corticosteroids or frequent hospitalizations
- Active central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- History of encephalopathy
- Recent bleeding from untreated or partially treated esophageal or gastric varices within 6 months
- Inadequate organ function including unstable heart failure, respiratory failure, uncontrolled infection, or other life-threatening condition
AI-Screening
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Trial Site Locations
Total: 14 locations
1
CHU de Besançon
Besançon, France
Actively Recruiting
2
CH William Morey
Chalon-sur-Saône, France
Actively Recruiting
3
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
4
Centre Georges François Leclerc
Dijon, France
Actively Recruiting
5
Hôpital Nord Franche-Comté
Montbéliard, France
Actively Recruiting
6
CHU de Montpellier
Montpellier, France
Actively Recruiting
7
CH de Mulhouse
Mulhouse, France
Actively Recruiting
8
Institut de Cancérologie de l'Ouest
Nantes, France
Not Yet Recruiting
9
Centre Hospitalier Paris St Joseph
Paris, France
Not Yet Recruiting
10
Groupe Hospitalier Paris Salpetrière
Paris, France
Actively Recruiting
11
Hôpital BEAUJON
Paris, France
Actively Recruiting
12
Institut Mutualiste Montsouris
Paris, France
Actively Recruiting
13
CHU de Poitiers
Poitiers, France
Not Yet Recruiting
14
Hôpital Paul Brousse
Villejuif, France
Actively Recruiting
Research Team
B
Borg Christophe, Pr
CONTACT
A
Angélique VIENOT, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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