Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Treatment for Unresectable HCC
NCT ID: NCT06360042
Last Updated: 2024-04-22
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
PHASE2
111 participants
INTERVENTIONAL
2024-01-01
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd)
Adebrelimab plus Apatinib
Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
2
Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w)
Adebrelimab plus Bevacizumab
Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
3
Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd)
Camrelizumab plus Apatinib
camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily
Interventions
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Adebrelimab plus Apatinib
Adebrelimab 1200mg intravenously every 3 weeks plus Apatinib 250mg orally once daily
Adebrelimab plus Bevacizumab
Adebrelimab 1200mg intravenously plus Bevacizumab 15 mg/kg intravenously every 3 weeks
Camrelizumab plus Apatinib
camrelizumab 200mg intravenously every 2 weeks plus Apatinib 250mg orally once daily
Eligibility Criteria
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Inclusion Criteria
* No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
* At least one measurable lesion per RECIST v1.1
* ECOG Performance Status of 0 or 1
* Child-Pugh class of A5 to B7
* Adequate organ function
Exclusion Criteria
* Moderate-to-severe ascites with clinical symptoms
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
* History of hepatic encephalopathy
* Previous or current presence of metastasis to central nervous system
18 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Responsible Party
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Principal Investigators
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Jun Zhou
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer 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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MA-HCC-II-021
Identifier Type: -
Identifier Source: org_study_id
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