This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Voronib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.
The participant must have received no more than two kinds of tyrosine kinase inhibitors (TKIs) medications (excluding mTOR inhibitors) and one type of immune checkpoint inhibitor treatment, with treatment failure in systemic antitumor therapy. Additionally, the participant must have completed the last systemic antitumor treatment ( chemotherapy,radiotherapy, targeted therapy, biological therapy, or endocrine therapy) at least 3 weeks prior, or at least 5 half-lives since the last systemic antitumor treatment. Furthermore, any treatment-related toxicities must have resolved to meet the laboratory test requirements for this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Volonib 200mg once daily and Everolimus 5mg once daily
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGProgression-free survival
The definition of Progression-free survival(PFS) is the time from the date of first dose until the first observation of disease progression (PD) (as determined by radiographic assessment) or death (whichever occurs first).
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Overall survival
Overall survival(OS) was defined as the time from the date of first dose to the date of death from any cause.
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Objective response rate
The Objective response rate(ORR) was defined as the proportion of patients with a best overall response of complete or partial response.
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Disease control rate
Disease control rate(DCR)was defined the proportion of patients with complete response, partial response, and stable disease.
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Duration of response
Duration of response (DOR)defined as the time from first documented response, PR or CR, to progressive disease \[PD\] or death; patients who neither progressed nor died were censored on the date of their last radiographic tumor assessment.
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Dynamic changes in ctDNA levels and alterations in the ctDNA mutation profile
In this study, blood samples were collected for ctDNA testing.
Time frame: In this study, a maximum of six blood samples were collected for ctDNA testing, specifically before treatment, and after drug treatment at 2 months, 4 months, 6 months, 8 months, and at the time of PD (progressive disease) occurrence up to 36 months
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