The study consists of two parts, the first part is a randomized, open-label, active-controlled study to evaluate the efficacy and safety of fruquintinib in combination with sintilimab versus axitinib or everolimus monotherapy as second-line treatment for locally advanced or metastatic renal cell carcinoma. The second part is a fruquintinib monotherapy factorial cohort study to evaluate the efficacy and safety of fruquintinib monotherapy as for second-line treatment of locally advanced or metastatic renal cell carcinoma.
The target populations for this study were patients with histologically or cytologically confirmed, locally advanced/ metastatic renal cell carcinoma who progressed during or after or intolerant to previous first-line VEGFR-TKI therapy. A total of about 249-264 patients are planned to be enrolled in the study, among whom about 234 patients are planned to be enrolled in the first part. The patients who are successfully enrolled will be randomly assigned into the investigational arm or the control arm in a 1:1 ratio. The enrollment of part 2 will be started after that of part 1 is completed. About 15\~30 patients are planned to be enrolled in the second part. The patients who are successfully enrolled will receive fruquintinib monotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
fruquintinib, 5 mg, QD, PO, 2 weeks on/1 week off, 3 weeks/cycle; sintilimab, 200 mg, IV infusion, Q3W, 3 weeks/cycle.
axitinib, 5 mg, twice daily (BID), PO, 3 weeks/cycle, dose escalation will be at the investigator 's discretion based on clinical; everolimus, 10 mg, QD, PO, 3 weeks/cycle.
fruquintinib, 5 mg, QD, PO, 3 weeks on/ 1 week off, 4 weeks/cycle.
Progression free survival (PFS) in Part I
PFS per RECIST 1.1 by BIRC
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Objective response rate (ORR) in Part II
ORR per RECIST 1.1 by investigator
Time frame: Time from the date of first treatment administration until disease progression or the introduction of a new treatment, assessed up to 20 months.
PFS
PFS per RECIST 1.1
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Safety in Part I
Severity and Incidence of Adverse event (AEs) and findings in Laboratory test, vital signs, 12-lead Electrocardiogram (ECG), etc. in Part I
Time frame: Through study completion, assessed up to 20 months.
Quality of life in Part I
Quality of life questionnaire analysis in Part I
Time frame: Through study completion, assessed up to 20 months.
Safety in Part II
Severity and incidence of AEs and findings in such as Laboratory test, vital signs, 12-lead ECG, etc. in Part II.
Time frame: Through study completion, assessed up to 20 months.
Disease control rate (DCR)
PFS per RECIST 1.1
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
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Beijing Chao-Yang Hospital, Capital Medical University
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Xiangya Hospital Central South University
Changsha, China
Sichuan Provincial People's Hospital
Chengdu, China
...and 38 more locations
ORR
ORR per RECIST 1.1
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Duration of response (DoR)
DoR per RECIST 1.1
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
Time to Response (TTR)
TTR per RECIST 1.1
Time frame: Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months.
OS
OS
Time frame: Time from date of randomization until the date of death from any cause, assessed up to 20 months.