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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Drug: sunitinib or pazopanib; Drug: PD-1 inhibitor combined with axitinib

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: jiwei huang, M.D; Phone Number: 8613651682825; Email: huangjiwei@renji.com
• Study Contact Backup: Name: wei xue; Phone Number: 86-21-68383776; Email: xuewei@renji.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: wei xue, M.D; Phone Number: 86-21-68383776; Email: xuewei@renji.com
      • Principal Investigator: wei xue, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: October 22, 2022
• First Submitted That Met QC Criteria: April 16, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: molecular classification; targeted therapy; metastatic renal cell carcinoma; ctDNA dynamic monitoring; targeted therapy combined with immunotherapy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib; Axitinib; Immune Checkpoint Inhibitors
• Other Study ID Numbers: MRCC-China collaboration

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No