Hepatocellular Carcinoma
Conditions
Keywords
CD4 Th1-inducer cancer vaccine
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)
Interventions
DRUGAtezolizumab
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
DRUGBevacizumab
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
DRUGUCPVax
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously
Sponsors
Centre Hospitalier Universitaire de Besancon
GERCOR - Multidisciplinary Oncology Cooperative Group
PRODIGE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective response rate (ORR) | at 6 months | addition of complete response (CR) and partial response (PR) rates, evaluated by mRECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | through study completion, an average of 2 years | delay from the date of randomization to death from any cause. |
| 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 |
Countries
France
Contacts
CONTACTBorg Christophe, Pr
CONTACTAngélique VIENOT, Dr
Outcome results
None listed