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

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ClinicalTrials.gov Identifier: NCT05816642

Recruitment Status : Recruiting

First Posted : April 18, 2023

Last Update Posted : April 18, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

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

Information provided by (Responsible Party):

RenJi Hospital

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	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	August 1, 2022
Estimated Primary Completion Date :	December 31, 2023
Estimated Study Completion Date :	December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib Sunitinib

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :

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 Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations