A Trial of Conversion Treatment of HAIC Combined With Camrelizumab and Apatinib for Unresected Hepatocellular Carcinoma
NCT05099848 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-05-22
Summary
The study is being conducted to evaluate the efficacy and safety of conversion treatment of Hepatic Arterial Infusion Chemotherapy combined with Camrelizumab and Apatinib for unresected hepatocellular carcinoma.
Conditions
Interventions
- DRUG
-
Camrelizumab
Procedure: 1. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 1st day 30minutes after meals, once a day, for continuous medication. 2. On the 2nd day of treatment, intravenous infusion of Camrelizumab 200mg every 3 weeks. 3. On the 3rd to 4th day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX, oxaliplatin 85 mg/m2 in 0-2 hours, folinic acid 400 mg/m2 in 2-3 hours, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 8 times. The cumulative maximum drug use period is up to 8 cycles. Patient will be administratied radical resection if possible during treatment. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
collaborator INDUSTRY -
Shandong Cancer Hospital and Institute
lead OTHER
Principal Investigators
-
Lei Zhao, MD · Shandong Cancer Hospital and Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-03-17
- Primary Completion
- 2024-01-31
- Completion
- 2024-05-31
Countries
- China
Study Locations
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