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Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC

Primary Purpose

Liver Cancer, Hepatocellular Carcinoma, Resistant Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lenvatinib Oral Product Plus VIC1911
Sponsored by
RenJi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Aurora A kinase inhibitor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lenvatinib plus VIC-1911 combination therapy

Arm Description

Subjects with lenvatinib unresponsive or lenvatinib resistant hepatocellular HCC will receive Lenvatinib plus VIC-1911 combination therapy.

Outcomes

Primary Outcome Measures

Progression free survival
Length of time from the start of combination therapy to progression of disease or death

Secondary Outcome Measures

Overall survival
Length of time from the date of first dose of combination therapy to date of death from any cause or latest follow-up
Safety endpoint
Statistically describe the proportion of adverse events after treatment for each patient

Full Information

First Posted
January 30, 2023
Last Updated
January 30, 2023
Sponsor
RenJi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05718882
Brief Title
Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC
Official Title
Safety and Efficacy of Lenvatinib Combined With VIC-1911 in the Treatment of Lenvatinib-unresponsive or Lenvatinib-resistant Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Hepatocellular Carcinoma, Resistant Cancer
Keywords
Aurora A kinase inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Bayesian Optimal Interval design
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lenvatinib plus VIC-1911 combination therapy
Arm Type
Experimental
Arm Description
Subjects with lenvatinib unresponsive or lenvatinib resistant hepatocellular HCC will receive Lenvatinib plus VIC-1911 combination therapy.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib Oral Product Plus VIC1911
Other Intervention Name(s)
aurora kinase A inhibitor
Intervention 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.
Primary Outcome Measure Information:
Title
Progression free survival
Description
Length of time from the start of combination therapy to progression of disease or death
Time Frame
6 months after the last subject is enrolled.
Secondary Outcome Measure Information:
Title
Overall survival
Description
Length of time from the date of first dose of combination therapy to date of death from any cause or latest follow-up
Time Frame
6 months after the last subject is enrolled
Title
Safety endpoint
Description
Statistically describe the proportion of adverse events after treatment for each patient
Time Frame
6 months after the last subject is enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Xia
Phone
008615800622858
Email
15003@renji.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hao Feng
Phone
008615000901110
Email
surgeonfeng@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang XIA
Organizational Affiliation
Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
Official's Role
Study Chair
Facility Information:
Facility Name
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Learn more about this trial

Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC

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