•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
398
Subjects receive Stereotactic Body Radiotherapy combined with Camrelizumab and Apatinib as conversion therapy.
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
Subjects receive Camrelizumab intravenously. Subjects receive Apatinib orally.
the First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Overall Survival
The primary endpoint of phase 3 study is OS
Time frame: Up to approximately 3 years
The R0 Resection rate of the experimental group
The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group
Time frame: Up to approximately 30 days
Objective Response Rate (ORR)
The ORR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Time frame: Up to approximately 3 years
Disease control rate (DCR)
The DCR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Time frame: Up to approximately 3 years.
Time to Response (TTR)
The TTR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Time frame: Up to approximately 3 years.
Duration of response (DoR)
The DoR is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
Time frame: Up to approximately 3 years.
Time to progression (TTP)
The TTP is assessed by The investigators according to RECIST v1.1 and mRECIST,
Time frame: Up to approximately 3 years.
Event free survival (EFS)
The EFS is assessed by the investigators according to RECIST v1.1 and mRECIST, respectively.
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If subjects suitable for hepatic resection after conversion therapy, radical surgery and postoperative adjuvant therapy will be performed.
Time frame: Up to approximately 3 years.
Conversion rate
The conversion rate of the experimental group.
Time frame: Up to approximately 30 days.
Resection rate
The resection rate of the experimental group.
Time frame: Up to approximately 30 days.
R0 resection rate
The R0 resection rate of the experimental group.
Time frame: Up to approximately 30 days.
Pathologic complete response (pCR) rate
The pCR rate of the experimental group.
Time frame: Up to approximately 30 days.
Major pathological response (MPR)
The MPR rate of the experimental group.
Time frame: Up to approximately 30 days.
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: Up to approximately 90 days.