SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.
NCT ID: NCT06739317
Last Updated: 2024-12-18
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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NOT_YET_RECRUITING
PHASE2/PHASE3
398 participants
INTERVENTIONAL
2025-01-01
2031-06-30
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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Experimental group
Radiation
Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.
First line therapy
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
operation
If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.
control group
First line therapy
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
Interventions
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Radiation
Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.
First line therapy
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
First line therapy
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
operation
If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or older.
* Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
* Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
* ECOG Performance Status of 0 or 1.
* Child-Pugh class of A.
Exclusion Criteria
* Existence of active autoimmune disease or history of autoimmune disease and may relapse.
* Patients with innate or acquired immune deficiency (e.g., HIV infection).
* Known allergies to study drugs or excipients.
18 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Ming Kuang
Professor
Locations
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the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Lixia Xu
Role: CONTACT
Facility Contacts
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Other Identifiers
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MA-HCC-II/III-030
Identifier Type: -
Identifier Source: org_study_id
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