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Not Yet RecruitingNCT05897138

A Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

A Phase 2, Multi-Center, Single Arm Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses

Status
Not Yet Recruiting
Phase
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Fujian Cancer Hospital · Other Government
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

Detailed description

The purpose of this study is to investigate the efficacy and safety of Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinoma With Hepatitis B Virus Infection and Biomarker Analyses.

Conditions

Interventions

TypeNameDescription
DRUGLenvatinib at a dose of 8 mg or 12 mg based on body weight + tislelizumab for one 21-day cycleDrug: Lenvatinib Capsules administered orally once daily Drug: Tislelizumab 200 mg intravenous (IV) infusion administered on Day 1 of each cycle

Timeline

Start date
2023-08-01
Primary completion
2025-06-01
Completion
2027-06-01
First posted
2023-06-09
Last updated
2023-06-13

Source: ClinicalTrials.gov record NCT05897138. Inclusion in this directory is not an endorsement.

A Study to Evaluate Lenvatinib Plus Tislelizumab for Locally Advanced Unresectable or Metastatic Hepatocellular Carcinom (NCT05897138) · Clinical Trials Directory