Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma

Not Applicable

Recruiting

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: sunitinib or pazopanib; Drug: PD-1 inhibitor combined with axitinib

• Registration Number: NCT05816642
• Lead Sponsor: RenJi Hospital

Brief Summary

Next-Generation Sequencing and whole transcriptome RNA sequencing were used to detect genomic variation and expression in tissues or blood, respectively. The treatment outcome of single targeted therapy or combined with immunotherapy was observed and followed up. Through this study, we intend to achieve RNA molecular classification of Chinese mRCC patients and to evaluate the correlation between ctDNA level, RNA molecular classification and treatment outcome, provide reference for metastatic RCC precise diagnosis and treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-10-22
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-16
• Last Update Submitted: 2023-04-16
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Clinically diagnosed with renal cell carcinoma confirmed by pathology, including clear renal cell carcinoma and type I papillary renal cell carcinoma, type II papillary renal cell carcinoma, chromophobe renal cell carcinoma and renal cell carcinoma with sarcomatoid differentiation, etc

  • Have distant metastasis
  • metastatic RCC
  • Eastern Cooperative Oncology Group 0 to 1
  • No obvious abnormality was found in blood routine examination, coagulation and liver and kidney function

Exclusion Criteria

• • Previously received systematic treatment

  • Failure to obtain baseline tumor tissue / blood samples
  • A history of infection with human immunodeficiency virus, or suffer from other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation, or have a history of organ transplantation
  • A history of allergy to disease treatment drugs
  • During lactation or pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single targeted therapy	sunitinib or pazopanib	sunitinib or pazopanib
targeted therapy combined with immunotherapy	PD-1 inhibitor combined with axitinib	Programmed death-ligand 1 Inhibitor combined with axitinib

Primary Outcome Measures

Name	Time	Method
progression-free survival	From drug taken until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	From drug taken until the date of first documented progression, assessed up to 20 months

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China