A Study of HAIC Combined With Lenvatinib and Envolizumab in Potentially Resectable Hepatocellular Carcinoma
NCT06143579 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2023-11-22
Summary
This is a single term, open label, single Center, Phase II Trial. The study is to explore the efficacy and safety of FOLFOX-HAIC combined with Lenvatinib and Envolizumab in the treatment of patients with potentially resectable HCC.
Conditions
- Potentially Resectable Hepatocellular Carcinoma
Interventions
- DRUG
-
FOLFOX-HAIC+Lenvatinib+Envolizumab
FOLFOX-HAIC: Oxaliplatin 130 or 85 mg/m2; leucovorin 200 mg/m2; fluorouracil 400 mg/m2 intravenous bolus followed by fluorouracil 2400 mg/m2 continuous infusion over 23 hours, Q3W, 2 to 4 cycles; Lenvatinib: 8 mg/day (BW \< 60 kg) or 12 mg/day (BW ≥ 60 kg), PO, 3-4 cycles; Envolizumab: 300 mg, SC, Q3W, 3-4 cycles.
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Zhongguo Zhou · Sun Yat-sen University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-15
- Primary Completion
- 2025-03-03
- Completion
- 2026-12-31
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