Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant (PLENTY202001)
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|ClinicalTrials.gov Identifier: NCT04425226|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : August 13, 2020
Objectives of Study：This study will evaluate the safety and efficacy of pembrolizumab in combination with lenvatinib as neoadjuvant therapy in participants with hepatocellular carcinoma (HCC) exceeding Milan criteria before liver transplant.
The primary hypothesis of this study are that neoadjuvant pembrolizumab plus lenvatinib is superior to regularly waiting in the list with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) Objective Response Rate (ORR).The investigators design a clinical study to explore whether the combination above as a neoadjuvant treatment in patients with advanced HCC before liver transplant could reduce postoperative recurrence and to analyze potential immune biomarker of therapeutic response.
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplant; Complications Hepatocellular Carcinoma Recurrent||Drug: Pembrolizumab Injection [Keytruda] Drug: Lenvatinib Oral Product||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy Study of Pembrolizumab in Combination With LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant as Neoadjuvant TherapY--PLENTY Randomized Clinical Trial|
|Actual Study Start Date :||August 6, 2020|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2024|
Experimental: Pembrolizumab plus Lenvatinib
Participants receive intravenous (IV) pembrolizumab at 200 mg on Day 1 of each 21-day cycle. Number of cycles: until >42 days before liver transplantation or unacceptable toxicity develops. Patients receive Lenvatinib 8-12mg(basing on weight), once a day, oral at least 38 days of each 6 weeks cycle until >7 days before liver transplantation.
Drug: Pembrolizumab Injection [Keytruda]
Pembrolizumab (Keytruda, MSD China) is a recombinant anti-human PD-1 monoclonal antibody.
Drug: Lenvatinib Oral Product
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
No Intervention: Comparator
Participants are advised to stay as healthy as possible and wait regularly
- Recurrence-Free Survival (RFS) [ Time Frame: Up to ~4 years ]RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death)
- Disease Control Rate (DCR) [ Time Frame: one year ]Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.
- Percentage of Participants who Experience an Adverse Event (AE) [ Time Frame: one year ]An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
- Percentage of Participants who Discontinue Study Treatment due to an AE [ Time Frame: Up to ~1 year ]An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.
- Objective Response Rate (ORR) [ Time Frame: one year ]Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04425226
|Contact: Hao Feng, MD., Ph.D.||firstname.lastname@example.org|
|Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University||Recruiting|
|Shanghai, China, 200127|
|Contact: Hao Feng, MD, PhD email@example.com|
|Study Chair:||Qiang Xia, MD., Ph.D.||Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU|
|Principal Investigator:||Hao Feng, MD., Ph.D.||Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU|