Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With SBRT for HCC Patients With Portal Vein Thrombosis.

Sponsor
National Taiwan University Hospital
Study ID
NCT05286320
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib/Pembrolizumab plus SBRT combinations — DRUG
    Five-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

Study Details

HCC patients with PVTT (main trunk or the first-degree branch) treated with the combination of pembrolizumab (Ketruda), lenvatinib (Lenvima), and SBRT.

Key Dates

First listed
Mar 18, 2022
Start date
Mar 1, 2023
Status verified
Sep 2022
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Target-/Immuno-therapy for advanced HCC w PVTT Lenvatinib/Pembrolizumab plus SBRT combinations
    Five-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

Primary Outcome Measure

safety rate [ Time Frame: The period to evaluate DLT is for 28 days after completion of SBRT. ]

Central Contacts

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