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

Metastatic Renal Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816642
• Other study ID #: MRCC-China collaboration
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: RenJi Hospital
• Contact: wei xue
• Phone: 86-21-68383776
• Email: xuewei[@]renji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

Drug:
• sunitinib or pazopanib
Single targeted therapy
• PD-1 inhibitor combined with axitinib
targeted therapy combined with immunotherapy

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (32)

Lead Sponsor

Collaborator

RenJi Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate		From drug taken until the date of first documented progression, assessed up to 20 months