Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation

Sponsor
Peking Union Medical College Hospital
Study ID
NCT06041490
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hepatocarcinoma
  • High-Risk Cancer
  • Liver Transplant; Complications
  • Recurrent Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • multi-kinase inhibitors in combination with bevacizumab — DRUG
    The 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.

Study Details

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.

Key Dates

First listed
Sep 18, 2023
Start date
Sep 30, 2023
Status verified
Aug 2023
Primary completion
Jun 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: multi-kinase inhibitors in combination with bevacizumab
    TKI (Sorafenib 400mg, bid, po or Lenvatinib 8mg, qd, po if bodyweight less than 60 kg,12mg, qd, po if bodyweight more than 60kg or Donafenib：200mg, bid, po) + bevacizumab：7.5mg/kg, infusion, Q3w
  • No Intervention: Without adjuvant therapy
    No intervention.

Primary Outcome Measure

EFFICACY: One-year recurrence-free survival rate (1-year RFS rate) [ Time Frame: Baseline up to 12 months ]

Central Contacts

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