This is a Phase Ib/II, open-label, single arm trial to evaluate the efficacy and safety of AK104 in combination with axitinib as a first-line treatment for advanced/metastatic special pathological subtypes of renal cell carcinoma (ssRCC). Subjects will receive AK104 plus axitinib until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR and PFS per RECIST v1.1 and imRECIST as assessed by investigators.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
West China Hospital
Chengdu, Sichuan, China
RECRUITINGORR per RECIST v1.1 and imRECIST as assessed by investigators
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1 and imRECIST
Time frame: 3 years
DCR per RECIST v1.1 and imRECIST as assessed by investigators
ORR is the proportion of subjects with complete response(CR), partial response(PR) or stable disease (SD) based on RECIST v1.1 and imRECIST
Time frame: 3 years
OS
OS is the time from the first use of a therapeutic drug to death from any cause
Time frame: 3 years
PFS per RECIST v1.1 and imRECIST as assessed by investigators
PFS is the time from the first use of a therapeutic drug to disease progression or death from any cause, progression is assessed by investigators based on RECIST v1.1 and imRECIST
Time frame: 3 years
Life quality Questionnaire composite
Evaluate life quality using EuroQol Five Dimensions Questionnaire (EQ-5D). EQ-5D included two aspects: EQ-5D Descriptive System and the EQ-5D visual analogue scale (EQ-VAS). In the description system, health status will be evaluated in 5 aspects: Mobility, Self-care, Usual Activities, Pain/Discomfort, Anxiety/Depression. EQ-VAS ranges from 0 to 100, higher scores indicate better health.
Time frame: 3 years
Pain score
Evaluate pain using visual analogue scale (VAS), range from 0 to 10, higher scores predict a poor prognosis.
Time frame: 3 years
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