HAIC (Hepatic Artery Infusion Chemotherapy,HAIC)Plus Sintilimab and Donafenib in the First-line Treatment of Unresectable Hepatocellular Carcinoma
NCT06244225 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2024-02-06
Summary
This is a single-arm exploratory clinical study to evaluate the efficacy and safety of HAIC in combination with Sintilimab and Donafenib in patients with BCLC-C stage who have not received prior systemic therapy
Conditions
Interventions
- DRUG
-
Donafenib; Sintilimab; HAIC
Drug: Sintilimab Q3W 200mg IV d1, Q3W Drug: Donafenib 200 mg BID d1-21, Q3W other: HAIC Q3W Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h.
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2026-01-01
- Completion
- 2028-01-01
Countries
- China
Study Locations
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