HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
NCT ID: NCT06333561
Last Updated: 2025-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2021-01-01
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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HAIC+Len+PD-1 inhibitor group
HAIC combined with Lenatinib and PD-1 inhibitor group
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.
Lenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
Tislelizumab
200mg intravenously every 3 weeks
Toripalimab
240mg intravenously every 3 weeks
Sintilimab
200mg intravenously every 3 weeks
Camrelizumab
200mg intravenously every 3 weeks
Len group
Lenvatinib alone
Lenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
Interventions
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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.
Lenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
Tislelizumab
200mg intravenously every 3 weeks
Toripalimab
240mg intravenously every 3 weeks
Sintilimab
200mg intravenously every 3 weeks
Camrelizumab
200mg intravenously every 3 weeks
Eligibility Criteria
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Inclusion Criteria
2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
3. Lenvatinib as initial treatment.
4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
5. no history of other malignancies.
6. no tumor thrombus in the atrium or vena cava.
Exclusion Criteria
2. under 18 years or over 75 years.
3. TACE as initial treatment.
4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
5. incomplete tumor imaging data.
6. lost to follow-up after treatment within three months.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Zhou Qunfang
Clinical Professor
Principal Investigators
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Feng Duan, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Liver Project 7
Identifier Type: -
Identifier Source: org_study_id
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