Metastatic Renal Cell CarcinomaNCT05816642
Application Circulating Tumor DNA Dynamic Monitoring in Clinical Treatment of Metastatic Renal Cell Carcinoma
A study testing sunitinib or pazopanib and PD-1 inhibitor combined with axitinib in people with Metastatic Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- sunitinib or pazopanib and PD-1 inhibitor combined with axitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
wei xue, M.D, 86-21-68383776, xuewei@renji.com
wei xue, M.D
About this study
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
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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- sunitinib or pazopanib, PD-1 inhibitor combined with axitinib
- Keywords
- metastatic renal cell carcinoma, molecular classification, ctDNA dynamic monitoring, targeted therapy, targeted therapy combined with immunotherapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib or pazopanibDrug
Single targeted therapy
PD-1 inhibitor combined with axitinibDrug
targeted therapy combined with immunotherapy
| Study group | Role | What they receive |
|---|---|---|
| Single targeted therapy | Active comparator | sunitinib or pazopanib Receives: Drug: sunitinib or pazopanib |
| targeted therapy combined with immunotherapy | Experimental | Programmed death-ligand 1 Inhibitor combined with axitinib Receives: Drug: PD-1 inhibitor combined with axitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 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 outcomes (1)
Objective Response Rate
Measured: From drug taken until the date of first documented progression, assessed up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Aug 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- 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, Zhejiang University, School of Medicine, 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 Province Cancer Hospital, Changzhi Medical College, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, The First Affiliated Hospital of Air Force Medical University, Tang-Du Hospital, Quanzhou First Hospital, Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816642
- Sponsor's protocol ID
- MRCC-China collaboration
- Status last verified
- Apr 2023
- First submitted
- 22 Oct 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05816642
- Acronym / sponsor ID
- MRCC-China collaboration
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- metastatic renal cell carcinoma, molecular classification, ctDNA dynamic monitoring, targeted therapy, targeted therapy combined with immunotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- 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, Zhejiang University, School of Medicine, 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 Province Cancer Hospital, Changzhi Medical College, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Xi'an Jiaotong University, The First Affiliated Hospital of Air Force Medical University, Tang-Du Hospital, Quanzhou First Hospital, Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single targeted therapy | Active comparator | Drug: sunitinib or pazopanibsunitinib or pazopanib |
| targeted therapy combined with immunotherapy | Experimental | Drug: PD-1 inhibitor combined with axitinibProgrammed death-ligand 1 Inhibitor combined with axitinib |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- • Previously received systematic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunitinib or pazopanibSingle targeted therapy | Drug | Single targeted therapy |
| PD-1 inhibitor combined with axitinibtargeted therapy combined with immunotherapy | Drug | targeted therapy combined with immunotherapy |
Primary outcome
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
1 secondary outcome
Objective Response Rate
Time frame: From drug taken until the date of first documented progression, assessed up to 20 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sunitinib or pazopanib and PD-1 inhibitor combined with axitinib in people with Metastatic Renal Cell Carcinoma, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei xue (86-21-68383776, xuewei@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.