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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 Transplantationļ¼iPLENTY-pvttļ¼
Study ID: NCT05339581
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 (Pembrolizumabļ¼Sintilimabļ¼ Camrelizumabļ¼Tislelizumab) 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, , China
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