At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed hepatocellular carcinoma
- ✓Locally advanced, metastatic, or unresectable disease
- ✓No prior systemic anti-cancer treatment
- ✓Age ≥18 years
- ✕Prior exposure to anti-PD-1, anti-PD-L1, or anti-CTLA4 immunotherapy
- ✕Additional malignancy within 3 years (except basal cell carcinoma, in situ cervical/breast cancer)
- ✕Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma-HCC
- ✕Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Atezolizumab, Bevacizumab, and 1 other intervention for Hepatocellular Carcinoma. Currently recruiting, targeting 105 participants across 14 sites.
Signals
Detailed 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)
Study Details
Timeline
Interventions
1200 mg IV every 3 weeks until disease progression or unacceptable toxicity
15 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity
UCPVax vaccine (combined with Montanide ISA51 as adjuvant) at 0.5 mg subcutaneously