Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
1. Explore the impact of postoperative administration of multi-kinase inhibitors (including sorafenib, lenvatinib, and regorafenib) in conjunction with bevacizumab on post-transplant recurrence, overall survival, and drug safety in liver transplant recipients at high risk of recurrence in hepatocellular carcinoma. 2. The primary objective of this study is to evaluate the efficacy of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the one-year recurrence-free survival rate (1-year RFS rate). 3. The secondary objectives of this study are to assess the effectiveness and safety of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the following parameters: Recurrence-free survival (RFS) duration, Overall survival (OS), Two-year and three-year RFS rates, Graft survival, Quality of life evaluation (QoL), Incidence of adverse events and serious adverse events.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary enrollment, accompanied by the signing of a written informed consent form, is a prerequisite for participation in this study. This ensures that participants enter the study based on their own decision and understanding of the research objectives, procedures, and potential risks.
The study includes individuals aged between 18 and 75 years, inclusive, without any gender restrictions. This broad age range and gender inclusivity allow for a diverse representation of participants, facilitating a comprehensive understanding of the study outcomes across different demographic profiles.
Prior to enrollment, participants must have undergone liver transplantation within the preceding 4 to 8 weeks. This specific time frame serves as an inclusion criterion to ensure that participants have recently undergone the surgical procedure, enabling researchers to investigate the effects of the transplantation within a relevant timeframe.
Participants should have an anticipated life expectancy of more than 3 months.
Disqualifiers
Patients with a previous histological/cytological diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other similar components.
Patients who have undergone potentially curative treatment and have no evidence of the disease within the past 5 years.
Patients who have successfully undergone resection of basal cell carcinoma, squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other in situ carcinomas; or patients who have been treated for superficial bladder cancer, have undergone surgical treatment, and have prostate-specific antigen (PSA) tumor markers within the normal range.
Patients who are concurrently taking medications that may prolong the QTc interval and/or induce torsades de pointes (Tdp) or medications that affect drug metabolism.
Trial design
Design model
Parallel
Treatments tested in this trial
multi-kinase inhibitors in combination with bevacizumab
DrugThe eligible participants will start taking multi-kinase inhibitors between 4-8 weeks after liver transplantation. The choice of the specific multi-kinase inhibitor, including sorafenib, lenvatinib, or regorafenib, will be determined by the researchers based on factors such as the participant's tumor characteristics, liver function, physical condition, risk of side effects, economic status, and personal preference. The specific dosage and administration details can be found in the table provided. The maximum duration of multi-kinase inhibitor treatment will be 12 months or until any of the following conditions occur, whichever comes first: 1) The participant experiences intolerable toxic reactions that do not alleviate with dose adjustments, or 2) The participant has documented disease recurrence confirmed through imaging or withdraws from the study for other reasons.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: multi-kinase inhibitors in combination with bevacizumabExperimental treatment 1 intervention
Group B: Without adjuvant therapyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
EFFICACY: One-year recurrence-free survival rate (1-year RFS rate)
One-year recurrence-free survival rate (1-year RFS rate): The one-year recurrence-free survival rate represents the proportion of patients, within a specified study population, who remain free from disease recurrence for at least one year following a designated treatment or intervention.
Time frame
Baseline up to 12 monthsSecondary outcomes
1
EFFICACY: Recurrence-free survival (RFS) duration
Recurrence-free survival (RFS) duration: From randomization to the time of disease recurrence evidence or any cause-induced mortality.
Time frame
Baseline up to approximately 12 months2
EFFICACY: Overall survival (OS)
Overall survival (OS): The duration from randomization to mortality caused by any underlying factors serves as a crucial metric for evaluating the impact of interventions on study participants.
Time frame
Baseline up to approximately 3 years3
EFFICACY: Two-year and three-year RFS rates
Two-year and three-year RFS rates: The two-year and three-year RFS rate represents the proportion of patients, within a specified study population, who remain free from disease recurrence for at least two or three year following a designated treatment or intervention.
Time frame
Baseline up to approximately 2-3 years4
EFFICACY and SAFETY: Graft survival
Graft survival: The interval between the commencement of randomization and the occurrence of graft loss is a pivotal time frame in transplantation research. In cases where patients are unaware of graft loss or when graft loss is not documented upon patient demise without confirmed graft loss, the time of graft loss is retrospectively evaluated using either the date of the last documented contact or the date of death.
Time frame
Baseline up to approximately 3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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