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Trial Title:
Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC
NCT ID:
NCT05718882
Condition:
Liver Cancer
Hepatocellular Carcinoma
Resistant Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Conditions: Keywords:
Aurora A kinase inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Bayesian Optimal Interval design
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Lenvatinib Oral Product Plus VIC1911
Description:
Lenvatinib: 8mg/day (≤ 60Kg), oral. VIC-1911:Groups were divided: 100mg bid（DL1, dose
level 1）; 150mg bid（DL2）; 200mg bid(DL3), oral. 50mg bid is defined as DL(-1), 250mg bid
is defined as DL(+1). A Bayesian Optimal Interval design schema will be followed to
establish the maximum tolerated dose (MTD) of lenvatinib plus VIC-1911 combination and
RP2D of VIC-1911 in HCC patients. The study would follow the Bayesian Optimal Interval
Design with level size of 2 patients. The R package "BOIN" is available from CRAN.
Arm group label:
Lenvatinib plus VIC-1911 combination therapy
Other name:
aurora kinase A inhibitor
Summary:
This is a prospective clinical study aiming to test the safety and efficacy of lenvatinib
in combination with Aurora kinase A inhibitor VIC-1911 in participate with
lenvatinib-unresponsive or lenvatinib-resistant hepatocellular carcinoma(HCC).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
(1) Unlimited gender, aged 18-75 years; (2) Meets American Association for the Study of
Liver Diseases (AASLD) or European Association for the Study of the Liver (EASL) clinical
diagnostic criteria of hepatocellular carcinoma; (3) Barcelona Clinic Liver Cancer (BCLC)
Stage C, and there is at least one measurable tumor in the liver (long diameter ≥
1cm);(4) Lenvatinib unresponsive or lenvatinib resistant after standard treatment; (5)
Child-Pugh A or scored 7 B; (6) Eastern Cooperative Oncology Group performance status
score <= 1; (7) Platelet count >= 60x10^9/L, Prothrombin time prolonged <= 6 seconds.
Exclusion Criteria:
(1) Uncorrectable coagulopathy with obvious bleeding tendency; (2) Patients need
long-term anticoagulant or anti platelet therapy and cannot stop the drugs; (3) Patients
with unstable or active ulcer or gastrointestinal bleeding; (4) Heart disease requiring
treatment or not well controlled high blood pressure; (5) Hepatic encephalopathy or
refractory ascites requiring treatment; (6) There is a clear active infection; (7)
Receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks
before the start of the study; (8) Severe insufficiency of important organs, such as
severe cardiopulmonary insufficiency; (9) Other accompanying anti-tumor treatments; (10)
The investigator assessed that the patient was unable or unwilling to comply with the
protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Qiang Xia, MD, PhD
Email:
xiaqiang@medmail.com.cn
Start date:
July 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05718882
