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Clinical Trials in France / NCT05528952
Recruiting Phase 2

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

NCT05528952 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2022-09-27
Last updated
2026-03-16

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

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

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Main inclusion Criteria: 1. Signed informed consent 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 Main exclusion Criteria: Non-eligible to a clinical trial: 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 Cancer-specific exclusion criteria: 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

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
CHU de Besançon Besançon France Recruiting
CH William Morey Chalon-sur-Saône France Recruiting
Hôpital Henri Mondor Créteil France Recruiting
Centre Georges François Leclerc Dijon France Recruiting
Hôpital Nord Franche-Comté Montbéliard France Recruiting
CHU de Montpellier Montpellier France Recruiting
CH de Mulhouse Mulhouse France Recruiting
Institut de Cancérologie de l'Ouest Nantes France Not Yet Recruiting
Centre Hospitalier Paris St Joseph Paris France Not Yet Recruiting
Groupe Hospitalier Paris Salpetrière Paris France Recruiting
Hôpital BEAUJON Paris France Recruiting
Institut Mutualiste Montsouris Paris France Recruiting
CHU de Poitiers Poitiers France Not Yet Recruiting
Hôpital Paul Brousse Villejuif France Recruiting

On this site

📄 Tecentriq (atezolizumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

More Centre Hospitalier Universitaire de Besancon trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05528952 on ClinicalTrials.gov ↗ ← All trials in France