HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.
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.
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.
Single group
Lenvatinib/Pembrolizumab plus SBRT combinations
DrugFive-fraction SBRT (week 4-week 5) to PVTT and connected HCC tumor in 2 weeks Lenvatinib 12/8 mg/day for 96 weeks (no lenvatinib from 7 day before SBRT to 7 days after SBRT) Pembrolizumab 200 mg q 3 week x 32 cycles
safety rate
In stage 0 and stage I interim analysis DLT will be assessed after 3 patients for each stage are accrued to the study. In stage II interim analysis for 6 (from stage 0 and I) + 6 (from stage II) patients, ≤4 patients with DLT and ≥6 patients with CR/PR are the criteria for stage III patient accrual.
objective response rate
Tumor measurements and response evaluations are conducted by an independent radiologist based on liver dynamic CT or MRI images at screening and every follow-up image after allocation. A second radiologist will perform an independent blinded image review at the end of the study without interfering with the primary judgment concerning disease progression and treatment decision. The response evaluation criteria are according to mRECIST.
Progression-free survival and overall survival
Survival outcomes are calculated from date of allocation. Progression is defined as progressive disease by mRECIST or death from any cause. Overall survival is the time from allocation to death from any cause. Survival curves are determined by the Kaplan-Meier method.
Immune biomarkers
1. Pre-treatment tumor tissue (i.e., biopsy or prior surgery) or blood sample is mandatory for biomarker study accompanying the clinical trial. 2. The collected biomarkers will be analyzed for the correlation with the response of portal vein tumor thrombosis, progression-free survival, and overall survival.
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