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

Hepatocellular Carcinoma Clinical Trial

Official title:

Safety and Efficacy of Lenvatinib Combined With VIC-1911 in the Treatment of Lenvatinib-unresponsive or Lenvatinib-resistant Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718882
• Other study ID #: Renji-LY2022-024-b
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: RenJi Hospital
• Contact: Lei Xia
• Phone: 008615800622858
• Email: 15003[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Cancer
• Resistant Cancer

Intervention

Drug:
• Lenvatinib Oral Product Plus VIC1911
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.

Locations

Country	Name	City	State
China	Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	Length of time from the start of combination therapy to progression of disease or death	6 months after the last subject is enrolled.
Secondary	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	6 months after the last subject is enrolled
Secondary	Safety endpoint	Statistically describe the proportion of adverse events after treatment for each patient	6 months after the last subject is enrolled