The Efficacy and Safety of TACE, Lenvatinib and Camrelizumab in the Treatment of BCLC Stage B/C Hepatocellular Carcinoma: a Single-arm, Single-center, Open-label Study
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study ID
- NCT04909866
- Phase
- PHASE2/PHASE3
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- TACE+Lenvatininb+Camrelizumab — COMBINATION_PRODUCTPatients included in the trial were treated with TACE, lenvatinib combined with Camrelizumab.
Study Details
This study is a single-center, single-arm, open-label prospective clinical trial. By recording the disease-free progression (PFS), overall survival (OS) and tumor treatment response of the included patients, it is planned to evaluate TACE, lenvatinib and carrelizumab in the treatment of BCLC B/C hepatocytes Survival benefits of cancer patients; at the same time, the immune indicators before and after treatment are tested, the dosage is optimized, and the mechanism of combination therapy in liver cancer is explored to lay the foundation for screening more suitable treatment populations; laboratory testing indicators and adverse events To observe and evaluate the safety of combined therapy; adopt immunohistochemistry, pathology, cell biology, proteomics and imagingomics methods to comprehensively evaluate the changes after combined therapy.
Key Dates
- Start date
- Jan 1, 2021
- Status verified
- May 2021
- Primary completion
- Sep 1, 2022
- Completion
- Dec 1, 2022
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: TACE+Lenvatinib+Camrelizumab
Primary Outcome Measure
PFS [ Time Frame: The period of time between the date of randomization until the date of first documented progression , assessed up to 24 months ]
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