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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Observational Study of Molecular Classification and Circulating Tumor DNA Dynamic Monitoring to Explore Related Factors That Predict the Efficacy of Single Targeted Therapy or Combined With Immunotherapy for Metastatic Renal Cell Carcinoma

Conditions
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Metastatic Renal Cell Carcinoma

Intervention / Treatment
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* Drug: sunitinib or pazopanib
* Drug: PD-1 inhibitor combined with axitinib


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single targeted therapy<br>sunitinib or pazopanib | Drug: sunitinib or pazopanib<br>* Single targeted therapy<br>|
| Experimental: targeted therapy combined with immunotherapy<br>Programmed death-ligand 1 Inhibitor combined with axitinib | Drug: PD-1 inhibitor combined with axitinib<br>* targeted therapy combined with immunotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate |  | From drug taken until the date of first documented progression, assessed up to 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic renal cell carcinoma, molecular classification, ctDNA dynamic monitoring, targeted therapy, targeted therapy combined with immunotherapy