Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05355155
Phase
PHASE2
Status
Unknown

Conditions

  • Hepatocellular Carcinoma Recurrent
  • Post-orthotopic Liver Transplantation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is a single arm, single center, prospective and open exploratory study. About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.

Key Dates

First listed
May 2, 2022
Start date
May 1, 2022
Status verified
May 2022
Primary completion
May 31, 2023
Completion
Dec 31, 2024

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab combine with FOLFOX4
    Bevacizumab biosimilar：7.5mg/kg，IV，D1，Q2W FOLFOX4： 1. Oxaliplatin: 85 mg/m2 , IV, D1，Q2W 2. Calcium leovorin: 200 mg/m2 ,IV, D1、D2，Q2W 3. Fluorouracil: 400 mg/m2 push infusion and given 600mg/m2 intravenously 22 hours later， D1、D2, Q2W Treatment will continue until disease progression, an unacceptable toxicity, or the patient voluntarily discontinues the study, whichever comes first.

Primary Outcome Measure

Objective Response Rate (ORR) ,Based on RECIST 1.1 [ Time Frame: From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years ) ]

Central Contacts

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