Neoadjuvant Combination of Atezolizumab/Bevacizumab Versus Neoadjuvant Radiation Therapy (NCT05137899) | Clinical Trial Compass
TerminatedPhase 2
Neoadjuvant Combination of Atezolizumab/Bevacizumab Versus Neoadjuvant Radiation Therapy
Stopped: Recruitment challenges, Hoffman La Roche strategic priority shift
Canada1 participantsStarted 2022-10-18
Plain-language summary
A multicentre, parallel group, randomized controlled Phase II clinical trial evaluating neoadjuvant Atezolizumab/Bevacizumab versus neoadjuvant SBRT in patients with biopsy proven solitary HCC with PVTT involving the portal vein branches. Both arms are considered experimental, and as such, a Simon two-stage design will be initially used within both arms. Only if both arms are deemed of interest for further study will a comparison between arms, using a pick-the-winner design, be conducted. Following the completion of neoadjuvant therapy, study participants will undergo a CT scan or MRI to assess tumour response to neoadjuvant therapy. Hepatic resection will be performed for those participants who meet the surgical resection criteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Biopsy proven solitary HCC without biliary invasion, or metastases,
✓. PVTT involving the portal vein branches: Vp1-Vp3 (Japanese Classification for HCC with PVTT, see Appendix II),
✓. \<10 cm maximal diameter on CT or MRI,
✓. Child-Pugh Class A (see Appendix III), within 14 days prior to randomization. (All parameters without transfusion within 3 months).
✓. Age \> 18 years.
Exclusion criteria
✕. Abnormal laboratory parameters (within 14 days of randomization):
✕. Hemoglobin \< 90 g/L
✕. Platelet count \< 75 x 109/L without transfusion
✕. INR \>1.25
✕. Serum creatinine \> 1.5 x ULN
✕. Urine dipstick for proteinuria \> 2 (unless a 24-hour urine collection demonstrates \< 1.5 g of protein in 24 hours.