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Spots Global Cancer Trial Database for IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation

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Trial Identification

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

Official Title: PILOT Study on the Safety and Efficacy of IMRT Combined With PD-1 Blockade and LEnvatinib as Neoadjuvant TherapY for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (Vp3) Before Liver Transplantationļ¼ˆiPLENTY-pvttļ¼‰

Study ID: NCT05339581

Study Description

Brief 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.

Detailed Description: In most criteria (e.g.Milan, UCSF, Up-to-seven), PVTT remains as an absolute contraindication for liver transplant due to the high rate of recurrence and poor prognosis. Neoadjuvant therapy has induced pathological responses in multiple tumor types and might decrease the risk of postoperative recurrence in HCC. The primary endpoint is the necrosis rate of PVTT and the primary tumor. Participants receive PD-1 Blockade (Pembrolizumabļ¼ŒSintilimabļ¼Œ Camrelizumabļ¼ŒTislelizumab) 200 mg intravenously on day 1 of a regular treatment cycle and Lenvatinib Mesylate Capsule (LenvimaĀ®) 8 mg orally once daily. 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 ā‰„50 Gy and ā‰¤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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, , China

Contact Details

Name: Qiang Xia, MD, Ph.D

Affiliation: Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

Role: STUDY_CHAIR

Name: Yong-rui Bai, MD

Affiliation: Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU

Role: STUDY_CHAIR

Name: Xiu-mei Ma, MD

Affiliation: Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU

Role: PRINCIPAL_INVESTIGATOR

Name: Xiao-hang Wang, MD

Affiliation: Dept. Radiotherapy, Renji Hospital, School of Medicine, SJTU

Role: PRINCIPAL_INVESTIGATOR

Name: Hao Feng, MD, Ph.D

Affiliation: Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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