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Liver Transplant; ComplicationsPLENTY202001NCT04425226

Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant

A study testing Pembrolizumab Injection [Keytruda] and Lenvatinib Oral Product in people with Liver Transplant; Complications and Hepatocellular Carcinoma Recurrent, run by RenJi Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pembrolizumab Injection [Keytruda] and Lenvatinib Oral Product
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteChina
Study dates
6 Aug 2020to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically or cytologically or by radiological criteria proven hepatocellular carcinoma（exceeding Milan criteria）; known mixed histology (e.g. hepatocellular carcinoma plus cholangiocarcinoma) or fibrolamellar variant is not allowed
  • Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) <1 week before the treatment of pembrolizumab in combination with lenvatinib. Randomization needs to occur within 1 weeks after recruitment in the waiting list.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1.
  • Has a Child-Pugh A-B7 liver score (5 to 7 points) within 7 days prior to Cycle 1, Day 1.
  • Has controlled hepatitis B (Hep B)
  • The estimate time length between enrollment and liver transplantation should be at least 3 months
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  • No prior systemic therapy, local therapy (TACE etc.)>6w
  • If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment).
  • Has adequate organ function.
  • Granulocytes >= 1,500/uL
  • Hemoglobin >= 8.5 g/dL; patients with recent or ongoing gastrointestinal bleed may not be transfused to reach the entry hemoglobin of 8.5 g/dL; physicians should ensure patients requiring transfusion prior to registration do not have an occult or clinically apparent gastrointestinal bleed
  • Platelets >= 75,000/uL
  • Creatinine =< 1.5 x upper limit of normal (ULN) (or creatinine clearance calculated >= 60 cc/minute)
  • Bilirubin =< 3 mg/dL
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 5 x ULN
  • Prothrombin time (PT)-international normalized ratio (INR) =< 1.7 (not required for patients on anticoagulation agents; patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists)
  • Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on a regimen of anti-hypertensive therapy
  • Significant history of cardiac disease is not allowed:
  • Congestive heart failure > class II New York Heart Association (NYHA) Myocardial infarction within 6 months prior to registration Serious myocardial dysfunction, defined as scintigraphically (multigated acquisition scan [MUGA], myocardial scintigram) determined absolute left ventricular ejection fraction (LVEF) below 45% or an LVEF on echocardiogram (ECHO) below the normal limit at the individual institution

Who cannot join

  • Surgery within the past 3 years.
  • Has had esophageal or gastric variceal bleeding within the last 6 months.
  • Has clinically apparent ascites on physical examination.
  • Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
  • Has received liver ablation, radiofrequency or microwave ablation, radiotherapy in the last 6 months.
  • Has a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis
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  • Has an active infection requiring systemic therapy.
  • Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has known active tuberculosis (TB; Bacillus tuberculosis).
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
  • Has received prior systemic anti-cancer therapy for HCC including investigational agents.
  • Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology.
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1.
  • Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.

Trial locations and contacts

1 site in 1 country.

Hao Feng, MD., Ph.D. contact

008615000901110

surgeonfeng@live.com

China1 site, 1 recruiting

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

    Shanghai, 200127

    Hao Feng, MD, PhD, surgeonfeng@live.com

    Recruiting

Other trials in China

About this study

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

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.

Read the detailed description

Participates would be randomly assigned (1:1) to experimental or Comparator/Control by computer-generated allocation based on the envelope method and the hierarchical block randomization method(hierarchy: BCLC stage and AFP level). The envelopes are sealed opaque, and sequentially numbered.Randomization is performed by the trial coordinator.The random number table and the block assignment number table will be kept confidential by the full-time secretary of this project.Center-stratified block-permuted randomization is used in this trial. Then permuted block randomization is used for each stratum with a block size of 4.

Being tested
Pembrolizumab Injection [Keytruda], Lenvatinib Oral Product

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab Injection [Keytruda]Drug

    Also called Keytruda, MK-3475, Pembrolizumab

    Pembrolizumab (Keytruda, MSD China) is a recombinant anti-human PD-1 monoclonal antibody.

  • Lenvatinib Oral ProductDrug

    Also called LENVIMA, Lenvatinib

    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

Study groups in NCT04425226
Study groupRoleWhat they receive
Pembrolizumab plus LenvatinibExperimentalParticipants 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.
Receives: Drug: Pembrolizumab Injection [Keytruda]; Drug: Lenvatinib Oral Product
ComparatorNo interventionParticipants are advised to stay as healthy as possible and wait regularly

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-Free Survival (RFS)

    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)

    Measured: Up to ~4 years

Secondary outcomes (4)

  1. Disease Control Rate (DCR)

    Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit.

    Measured: one year

  2. Percentage of Participants who Experience an Adverse Event (AE)

    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.

    Measured: one year

  3. Percentage of Participants who Discontinue Study Treatment due to an AE

    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.

    Measured: Up to ~1 year

  4. Objective Response Rate (ORR)

    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.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start6 Aug 2020
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04425226
Sponsor's protocol ID
Renji-IIT-2020-0005
Acronym
PLENTY202001
Status last verified
Aug 2020
First submitted
8 Jun 2020
Last updated
13 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Pembrolizumab Injection [Keytruda] and Lenvatinib Oral Product in people with Liver Transplant; Complications and Hepatocellular Carcinoma Recurrent, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hao Feng, MD., Ph.D. (008615000901110, surgeonfeng@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-Free Survival (RFS) (time frame: Up to ~4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04425226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020.

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