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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2

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

Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: No

• 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.

• Male participants:

• A male participant must agree to use a contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 220 days after the last dose of study treatment and refrain from donating sperm during this period.

• A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:

• 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.

• Have measurable disease based on mRECIST.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.

• Have adequate organ function as defined in the following criteria (Specimens must be collected within 10 days prior to the start of study intervention) :(1)Absolute neutrophil count (ANC) ≥1500/µL. (2)Platelets ≥100000/µL. (3)Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L. (4)Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN. (5)Total bilirubin ≤1.5 ×ULN (mg/dL) OR direct bilirubin ≤ULN for participants with total bilirubin levels >2.5 × ULN (mg/dL).(6)AST (SGOT) and ALT (SGPT) ≤5 × ULN. (7)Alkaline phosphatase ≤2 × ULN.(8)Child-Pugh class Class A. (9)International normalized ratio (INR) OR prothrombin time (PT)、Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.

• Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative anti-viral therapy at least 4 weeks prior to starting study intervention. Participants with HBV will be eligible as long as they meet the following criteria: (1) Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to starting study intervention. (2)Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention.

• Patients have PVTT in the main trunk (VP4) or central branch (VP3).

• Previous liver resection, embolization, or ablative therapy is permitted.

Other Locations
National Taiwan University Hospital
Taipei City
Contact Information
Chia-Hsien Cheng
Time Frame
Start Date: October 1, 2022
Estimated Completion Date: September 30, 2026
Target number of participants: 27
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
Chia-Hsien Cheng
Leads: National Taiwan University Hospital

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