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NOT YET RECRUITING
NCT07630363
PHASE1/PHASE2

PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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."

Official title: A Study on the Safety and Efficacy of Atorvastatin in Combination With Axitinib and Toripalimab for Advanced Renal Cell Carcinoma Guided by Drug Sensitivity Testing Using Patient-Derived Tumor Cell Models

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-05-14

Completion Date

2030-04-01

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DRUG

Axitinib

Axitinib 5 mg orally twice daily.

DRUG

Toripalimab

Toripalimab 240 mg intravenously every 3 weeks.

DRUG

Atorvastatin

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

Locations (1)

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

Beijing, Chaoyang District, China