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Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Lenvatinib Combined with VIC-1911

Study type

Interventional

Funder types

Other

Identifiers

NCT06519721
RJ-LY2022-024-B

Details and patient eligibility

About

This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.

Full description

This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.

Purpose of the Study:

To observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer.

Sample Size:

According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase.

Study Subjects:

Patients with advanced HCC

Enrollment

15 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Gender unrestricted, age 18-75 years;
  • HCC conforms to AASLD or EASL clinical diagnostic standards;
  • HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm);
  • Liver function Child-Pugh Class A or Class B with a score of 7;
  • ECOG score of 0-1;
  • Platelet count ≥60×10^9/L, PT time prolongation ≤6 seconds.

Exclusion criteria

  • Irreversible coagulation dysfunction, with obvious bleeding tendency;
  • Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication;
  • Patients with unstable or active ulcers, gastrointestinal bleeding;
  • Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher;
  • Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction;
  • Patients with hepatic encephalopathy or refractory ascites requiring treatment;
  • Human Immunodeficiency Virus (HIV) infection;
  • Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (activity defined as viral load > 20000 IU/mL), or HBV, HCV positive patients who refuse to accept standardized antiviral treatment;
  • Inability to swallow oral medication.
  • Gastrointestinal diseases that may affect the absorption or tolerance of the study medication.
  • History of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening.
  • Known allergy to VIC-1911 or its components.
  • Within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed;
  • Other concurrent antitumor treatments;
  • The researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Phase 1: Accelerated titration phase
Experimental group
Description:
Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen.
Treatment:
Drug: Lenvatinib Combined with VIC-1911
Phase 2: Expansion phase
Experimental group
Description:
According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.
Treatment:
Drug: Lenvatinib Combined with VIC-1911

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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