Trials / Recruiting
RecruitingNCT06333561
HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.
Detailed description
This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Hepatic arterial infusion chemotherapy | Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. |
| DRUG | Lenvatinib | 12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day |
| DRUG | Tislelizumab | 200mg intravenously every 3 weeks |
| DRUG | Toripalimab | 240mg intravenously every 3 weeks |
| DRUG | Sintilimab | 200mg intravenously every 3 weeks |
| DRUG | Camrelizumab | 200mg intravenously every 3 weeks |
Timeline
- Start date
- 2021-01-01
- Primary completion
- 2024-12-30
- Completion
- 2025-12-30
- First posted
- 2024-03-27
- Last updated
- 2025-02-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06333561. Inclusion in this directory is not an endorsement.