PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC

NCT07630363 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: NCC022697
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Advanced Renal Cell Carcinoma (RCC); PTC; Atorvastatin; Targeted Therapy Combined With Immunotherapy

Keywords

Advanced Renal Cell Carcinoma (RCC); Patient-derived Tumor Cell Clusters; Drug Sensitivity Testing; Atorvastatin; Targeted Therapy Combined with Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) according to RECIST version 1.1.

  From baseline until disease progression, death, withdrawal, or end of treatment, assessed up to 24 months.

Secondary Outcomes (8)

• Progression-Free Survival (PFS)

  From treatment initiation until disease progression or death, assessed up to 24 months.

• Overall Survival (OS)

  From treatment initiation until death from any cause, assessed up to 48 months.

• Disease Control Rate (DCR)

  From baseline until disease progression, assessed up to 24 months.

• 12-Month Progression-Free Survival Rate

  12 months after treatment initiation.

• 12-Month Overall Survival Rate

  12 months after treatment initiation.

Study Arms (2)

Axitinib + Toripalimab

ACTIVE COMPARATOR

Participants will receive axitinib 5 mg orally twice daily and toripalimab 240 mg intravenously every 3 weeks as standard targeted therapy combined with immunotherapy.

Drug: Axitinib; Drug: Toripalimab

Atorvastatin + Axitinib + Toripalimab

EXPERIMENTAL

Participants will receive axitinib 5 mg orally twice daily, toripalimab 240 mg intravenously every 3 weeks, and atorvastatin calcium 10 mg orally once daily based on patient-derived tumor-like cell cluster drug sensitivity testing.

Drug: Axitinib; Drug: Toripalimab; Drug: Atorvastatin

Interventions

Axitinib DRUG

Axitinib 5 mg orally twice daily.

Atorvastatin + Axitinib + Toripalimab; Axitinib + Toripalimab

Toripalimab DRUG

Toripalimab 240 mg intravenously every 3 weeks.

Atorvastatin + Axitinib + Toripalimab; Axitinib + Toripalimab

Atorvastatin DRUG

Atorvastatin calcium 10 mg orally once daily, administered based on patient-derived tumor-like cell cluster drug sensitivity testing.

Atorvastatin + Axitinib + Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily agree to participate in the study and be willing and able to sign the informed consent form.
• Histologically confirmed clear cell renal cell carcinoma.
• 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.
• Estimated life expectancy of more than 3 months.
• Aged 18 to 75 years.
• Adequate major organ function and hematologic function, including:
• Absolute neutrophil count ≥1500 cells/μL without granulocyte colony-stimulating factor support within 2 weeks before Cycle 1 Day 1.
• Platelet count ≥80 × 10\^9/L.
• White blood cell count ≥2500/μL and ≤15000/μL without G-CSF support.
• Lymphocyte count ≥500/μL.
• Hemoglobin ≥9.0 g/dL, without erythropoietin dependence and without packed red blood cell transfusion within the previous 2 weeks.
• ALT, AST, and alkaline phosphatase ≤3 × upper limit of normal; ≤5 × upper limit of normal is allowed for liver metastases. For participants with bone metastases, alkaline phosphatase ≤5 × upper limit of normal is allowed.

You may not qualify if:

• 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.
• Uncontrolled diabetes mellitus, defined as fasting blood glucose \>1.5 × upper limit of normal. Participants may be enrolled after glucose-lowering treatment if adequately controlled.
• Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued bisphosphonate or denosumab therapy.
• QTc interval \>480 ms.
• Inadequate recovery from toxicity or complications caused by major surgery before treatment initiation.
• Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that may affect absorption of study drugs.
• Clinically significant hematuria, hematemesis, or hemoptysis of more than 0.5 teaspoon, approximately 2.5 mL, of red blood within 12 weeks before the first dose, or any other significant bleeding history.
• Significant cardiovascular impairment within 12 months before the first dose, including New York Heart Association class II or higher congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or hemodynamically unstable arrhythmia. Participants with left ventricular ejection fraction below the institutional lower limit of normal are also excluded.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, Beijing 101205

Beijing, Chaoyang District, 100021, China

Location

MeSH Terms

Interventions

Axitinib; toripalimab; Atorvastatin

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

xiongjun YE

CONTACT

010-87787170; yexiongjun@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: Axitinib + Toripalimab；Axitinib + Toripalimab + Atorvastatin

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 5, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)