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

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05816642

Collaborator

Ruijin Hospital (Other), Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other), West China Hospital (Other), Xiangya Hospital of Central South University (Other), Fudan University (Other), Second Affiliated Hospital, School of Medicine, Zhejiang University (Other), Second Affiliated Hospital of Nantong University (Other), Peking University First Hospital (Other), Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other), Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other), Zhejiang University (Other), First Affiliated Hospital of Wenzhou Medical University (Other), Sir Run Run Shaw Hospital (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other), The General Hospital of Eastern Theater Command (Other), The First Affiliated Hospital with Nanjing Medical University (Other), The First Affiliated Hospital of University of Science and Technology of China (Other), The Second Hospital of Anhui Medical University (Other), Tongji Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other), Peking Union Medical College Hospital (Other), The First Affiliated Hospital of Shanxi Medical University (Other), Shanxi Provincial Cancer Hospital (Other), Changzhi Medical College (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), Second Affiliated Hospital of Xi'an Jiaotong University (Other), Xijing Hospital of Air Force Military Medical University (Other), Tang-Du Hospital (Other), Quanzhou First Hospital Affiliated to Fujian Medical University (Other), Third Affiliated Hospital, Sun Yat-Sen University (Other)

500

Enrollment

Location

Arms

Anticipated Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Renal Cell Carcinoma	Drug: sunitinib or pazopanib Drug: PD-1 inhibitor combined with axitinib	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Single targeted therapy sunitinib or pazopanib	Drug: sunitinib or pazopanib Single targeted therapy
Experimental: targeted therapy combined with immunotherapy Programmed death-ligand 1 Inhibitor combined with axitinib	Drug: PD-1 inhibitor combined with axitinib targeted therapy combined with immunotherapy

Arm

Intervention/Treatment

Active Comparator: Single targeted therapy

sunitinib or pazopanib

Drug: sunitinib or pazopanib

Single targeted therapy

Experimental: targeted therapy combined with immunotherapy

Programmed death-ligand 1 Inhibitor combined with axitinib

Drug: PD-1 inhibitor combined with axitinib

targeted therapy combined with immunotherapy

Outcome Measures

Primary Outcome Measures

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

Objective Response Rate [From drug taken until the date of first documented progression, assessed up to 20 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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