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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Drug: sunitinib or pazopanib; Drug: PD-1 inhibitor combined with axitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05816642

MRCC-China collaboration

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Single targeted therapy

Active Comparator group

Description:

sunitinib or pazopanib

Treatment:

Drug: sunitinib or pazopanib

targeted therapy combined with immunotherapy

Experimental group

Description:

Programmed death-ligand 1 Inhibitor combined with axitinib

Treatment:

Drug: PD-1 inhibitor combined with axitinib