Back to resultsApplication Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
Primary Purpose
Metastatic Renal Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sunitinib or pazopanib
PD-1 inhibitor combined with axitinib
Sponsored by
About this trial
This is an interventional screening trial for Metastatic Renal Cell Carcinoma focused on measuring metastatic renal cell carcinoma, molecular classification, ctDNA dynamic monitoring, targeted therapy, targeted therapy combined with immunotherapy
Eligibility Criteria
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
Sites / Locations
- Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single targeted therapy
targeted therapy combined with immunotherapy
Arm Description
sunitinib or pazopanib
Programmed death-ligand 1 Inhibitor combined with axitinib
Outcomes
Primary Outcome Measures
progression-free survival
Secondary Outcome Measures
Objective Response Rate
Full Information
NCT ID
NCT05816642
First Posted
October 22, 2022
Last Updated
April 16, 2023
Sponsor
RenJi Hospital
Collaborators
Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, West China Hospital, Xiangya Hospital of Central South University, Fudan University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Second Affiliated Hospital of Nantong University, Peking University First Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The General Hospital of Eastern Theater Command, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of University of Science and Technology of China, The Second Hospital of Anhui Medical University, Tongji Hospital, The First Affiliated Hospital of Zhengzhou University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, The First Affiliated Hospital of Shanxi Medical University, Shanxi Provincial Cancer Hospital, Changzhi Medical College, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xijing Hospital of Air Force Military Medical University, Tang-Du Hospital, Quanzhou First Hospital Affiliated to Fujian Medical University, Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05816642
Brief Title
Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
Collaborators
Ruijin Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, West China Hospital, Xiangya Hospital of Central South University, Fudan University, Second Affiliated Hospital, School of Medicine, Zhejiang University, Second Affiliated Hospital of Nantong University, Peking University First Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University, Sir Run Run Shaw Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The General Hospital of Eastern Theater Command, The First Affiliated Hospital with Nanjing Medical University, The First Affiliated Hospital of University of Science and Technology of China, The Second Hospital of Anhui Medical University, Tongji Hospital, The First Affiliated Hospital of Zhengzhou University, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, The First Affiliated Hospital of Shanxi Medical University, Shanxi Provincial Cancer Hospital, Changzhi Medical College, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, Xijing Hospital of Air Force Military Medical University, Tang-Du Hospital, Quanzhou First Hospital Affiliated to Fujian Medical University, Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma
Keywords
metastatic renal cell carcinoma, molecular classification, ctDNA dynamic monitoring, targeted therapy, targeted therapy combined with immunotherapy
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single targeted therapy
Arm Type
Active Comparator
Arm Description
sunitinib or pazopanib
Arm Title
targeted therapy combined with immunotherapy
Arm Type
Experimental
Arm Description
Programmed death-ligand 1 Inhibitor combined with axitinib
Intervention Type
Drug
Intervention Name(s)
sunitinib or pazopanib
Intervention Description
Single targeted therapy
Intervention Type
Drug
Intervention Name(s)
PD-1 inhibitor combined with axitinib
Intervention Description
targeted therapy combined with immunotherapy
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
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 Measure Information:
Title
Objective Response Rate
Time Frame
From drug taken until the date of first documented progression, assessed up to 20 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei xue
Phone
86-21-68383776
Email
xuewei@renji.com
First Name & Middle Initial & Last Name or Official Title & Degree
jiwei huang, M.D
Phone
8613651682825
Email
huangjiwei@renji.com
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wei xue, M.D
Phone
86-21-68383776
Email
xuewei@renji.com
First Name & Middle Initial & Last Name & Degree
wei xue, M.D
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
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