About this trial
HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.
Eligibility criteria
Qualifiers
Male/female participants who are at least 20 years of age on the day of signing informed consent with histologically confirmed diagnosis of HCC or those diagnosed by the EASL non-invasive criteria for HCC will be enrolled in this study.
Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 during the treatment period and for at least 150 days after the last dose of study treatment.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Disqualifiers
A WOCBP who has a positive urine pregnancy test within 72 hours prior to [allocation]. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Has received prior systemic anti-HCC therapy including investigational agents or other local therapy within 4 weeks prior to [allocation].
Has received prior radiotherapy to non-liver sites within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
Trial design
Treatments tested in this trial
- Lenvatinib/Pembrolizumab plus SBRT combinations