IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation

Summary

This is a parallel assigned, open-label, perspective trial studying the safety and efficacy of intensity-modulated radiotherapy (IMRT) combined with PD-1 Blockade and Lenvatinib for Hepatocellular Carcinoma (HCC) with Vp3 Portal Vein Tumor Thrombus (PVTT, Japanese Liver Cancer Study Group classification) before liver transplantation.

Conditions

• Liver Cancer
• Liver Transplant; Complications
• Hepatocellular Carcinoma
• Portal Vein Thrombosis
• Radiotherapy; Complications

Interventions

RADIATION

intensity-modulated radiotherapy

Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.

COMBINATION_PRODUCT

Pembrolizumab

Participants receive PD-1 Blockade (Pembrolizumab 200mg，Sintilimab 200mg， Camrelizumab 200mg，Tislelizumab 200mg) 100-200 mg intravenously on day 1 of a regular treatment cycle until \>42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until \>7 days before liver transplantation.

DRUG

Sintilimab

Sintilimab is a recombinant anti-human PD-1 monoclonal antibody.

DRUG

Camrelizumab

Camrelizumab is a humanized anti-human PD-1 monoclonal antibody.

DRUG

Tislelizumab

Tislelizumab is a recombinant anti-human PD-1 monoclonal antibody.

DRUG

Lenvatinib Mesylate Capsule

Lenvatinib (Lenvima®, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.

Sponsors & Collaborators

• RenJi Hospital

  lead OTHER

Principal Investigators

• Qiang Xia, MD, Ph.D · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

• Yong-rui Bai, MD · Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU

• Xiu-mei Ma, MD · Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU

• Xiao-hang Wang, MD · Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU

• Hao Feng, MD, Ph.D · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-20

Primary Completion

2023-12-31

Completion

2024-05-31

Countries

• China

Study Locations