NCT05286320

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

Phase Ib/II Trial of Combining Pembrolizumab and Lenvatinib With Stereotactic Body Radiotherapy for Hepatocellular Carcinoma Patients With Portal Vein Thrombosis.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Protocol treatment includes : Pembrolizumab is intravenously infused every 3 weeks and lenvatinib is orally given every day for a total of 2 years. SBRT (5 fractions within 17 days) to the PVTT and adjacent connecting HCC tumor is delivered in the second cycle of pembrolizumab, with the discontinuation of lenvatinib 7 days before and after SBRT.

Conditions

• Unresectable Hepatocellular Carcinoma
• Pembrolizumab
• Lenvatinib
• Stereotactic Body Radiotherapy

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2022-03-18
• Last updated: 2023-03-02

Locations

1 site across 1 country: Taiwan