PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC (NCT07630363) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC
China40 participantsStarted 2026-05-14
Plain-language summary
Given the significant challenge of drug resistance in patients with advanced renal cell carcinoma (RCC) despite standard treatment, this study aims to translate preclinical findings into clinical practice, preliminarily evaluating the safety, tolerability, and preliminary efficacy of atorvastatin calcium combined with targeted and immunotherapy in patients with advanced RCC. We hypothesize that for some patients with advanced RCC who do not respond well to targeted + immunotherapy, identifying potential beneficiaries based on their PTC susceptibility testing and combining atorvastatin with these treatments in real-world settings could be an effective susceptibility enhancement strategy, thereby further improving patient survival. This prospective clinical study aims to validate the safety and efficacy of this "organoid-guided precision combination therapy model."
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily agree to participate in the study and be willing and able to sign the informed consent form.
. Advanced renal cell carcinoma not suitable for curative surgery or radiotherapy, or metastatic renal cell carcinoma, AJCC stage IV.
. No prior systemic therapy for renal cell carcinoma, except for prior adjuvant or neoadjuvant therapy for completely resectable renal cell carcinoma, provided that the therapy did not include agents targeting VEGF or VEGFR and recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy.
. At least one measurable lesion according to RECIST version 1.1.
. Karnofsky Performance Status score ≥70.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines three treatments — atorvastatin, axitinib, and toripalimab — which is a fairly complex regimen; can you walk me through how each of these works and why adding a statin like atorvastatin to a targeted therapy and immunotherapy combination might matter for my type of kidney cancer?
2Since this is a Phase 1/Phase 2 trial that isn't even recruiting yet, what does that mean for how much is already known about the safety of this specific combination, and how would that uncertainty compare to the established safety profile of standard axitinib-plus-immunotherapy regimens I might already be eligible for?
3The trial is measuring Objective Response Rate as its main goal — can you explain what that means in practical terms for me, and whether that's the kind of outcome that would matter most given where my cancer stands right now?
4Because this trial hasn't started recruiting yet, is there a realistic timeline for when it might open and enrol patients, and would waiting for it potentially affect my treatment options in the meantime?
5Would a standard first-line treatment for advanced RCC be a better starting point for me right now, and if my cancer progresses or doesn't respond well, could I potentially still be considered for a trial like this one later?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From baseline until disease progression, death, withdrawal, or end of treatment, assessed up to 24 months.
Trial details
NCT IDNCT07630363
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Estimated life expectancy of more than 3 months.
. Aged 18 to 75 years.
Exclusion criteria
. Prior systemic therapy for renal cell carcinoma, unless the investigator can provide evidence that the participant was assigned to a placebo group.
. Known central nervous system metastases.
. Active malignancy within the past 24 months, except for renal cell carcinoma, definitively treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix or bladder. Participants with a history of localized low-risk prostate cancer may be eligible if they received curative treatment and have had no prostate-specific antigen recurrence within the past 5 years.
. Radiotherapy within 21 days before initiation of study treatment, except palliative radiotherapy for bone lesions completed at least 2 weeks before study treatment.
. Participation in another clinical study or receipt of an investigational drug within 4 weeks before initiation of study treatment.
. Receipt of a live vaccine within 30 days before planned initiation of study treatment.
. Proteinuria \>1+ on urine dipstick. Participants with urine protein ≥1 g/24 hours on 24-hour urine collection are not eligible.
. Fasting total cholesterol \>300 mg/dL, equivalent to 7.75 mmol/L, and/or fasting triglycerides \>2.5 × upper limit of normal.