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PTC-Guided Atorvastatin Plus Axitinib and Toripalimab in Advanced RCC

NCT07630363 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-14
Primary Completion
2028-03-01
Completion
2030-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07630363 on ClinicalTrials.gov