This study is a single-arm, multicenter clinical study to evaluate the efficacy and safety of SBRT combined with cardonilizumab and lenvastinib in the treatment of unresectable hepatocellular carcinoma with portal vein tumor thrombus
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Cadonilimab will be administered within 2 weeks after the completion of the radiotherapy treatment once every 3 weeks (Q3W), for up to 2 years
Radiation therapy: Stereotactic radiotherapy (5-8Gy\*5F) for portal vein thrombus within 21 days after entry
Renvatinib: 8mg (weight \<60kg) or 12mg (weight 60kg) once a day until disease progression, intolerable toxicity
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGObjective response rate(ORR)
ORR is proportion of patients with complete response(CR) or partial response(PR) assessed by investigators according to RECIST v1.1.
Time frame: Up to approximately 2 years
3-month PFS rate
3-month PFS rate is the percentage of patients whose disease has not progressed within 3 months.
Time frame: Up to approximately 2 years
progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the first dose of Cadonilimab until documentation of PD (as per RECIST v1.1) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Disease control rate (DCR)
DCR is proportion of patients with complete response, partial response or stable disease assessed by investigators according to RECIST v1.1.
Time frame: Up to approximately 2 years
Duration of response (DOR)
Duration of Response (DOR) is defined as the time between the first assessment of a tumor as Complete Response(CR)or Partial Response(PR)and the first assessment of Progressive Disease (PD) or death from any cause.
Time frame: Up to approximately 2 years
Overall Survival (OS)
Overall survival (OS) is defined as the time from the first dose of Cadonilimab until death due to any cause
Time frame: Up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.