Metastatic Clear Cell Renal Cell CarcinomaPhase 2PERFUMER-70NCT07615348
CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk
A Phase 2 study testing PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Jinling Hospital, China at 5 sites in China.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Clear Cell Renal Cell Carcinoma
- What is being tested?
- PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesChina
- Study dates
- 16 Jun 2026to 10 Aug 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEP0: At Treatment Initiation
- Male or female subjects aged ≥ 18 years
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype
- Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- Karnofsky Performance Status (KPS) grade ≥ 70%
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- At least one measurable lesion on CT per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- At least one high-uptake target lesion on CD70-targeted immuno-PET/CT per Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) version 1.0
- If CD70-negative lesions (visible on CT but lacking CD70 avidity on PET/CT) are present at baseline, they must meet ALL the following conditions: cannot be target lesions, cannot be located in major involved organs, must be ≤ 3 in number, and must account for ≤ 30% of the total tumor burden
- Adequate organ and bone marrow function meeting all laboratory criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥90 g/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × upper limit of normal(ULN) (or ≤ 5 × ULN if hepatic metastases are present). Total bilirubin ≤ 1.5 × ULN (≤ 3 mg/dL if Gilbert's syndrome)
- Serum creatinine ≤ 2.0 × ULN or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min using the Cockcroft-Gault formula
- Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
- Contraception agreement for sexually active fertile participants and partners to use medically accepted methods during the study and continue for 5 months after last treatment
- Negative pregnancy status at screening for women of childbearing potential
- STEP1: At 12-Month Evaluation
- Patient met all eligibility criteria outlined above
- Patient must receive 12 months (±1m) of first line PD-1/PD-L1 ICI + VEGFR-TKI therapy, without permanent discontinuation of both agents due to unmanageable toxicity
- Patient must have completed an CD70-targeted immuno-PET/CT scan at 12m (±1m) from start of initial therapy
- Patients must meet one of the following criteria:
- Eligible for treatment discontinuation: For CD70-Positive Lesions: Sustained Disease Control (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]) on CT for ≥ 12 weeks per RECIST 1.1, AND achieved Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET/CT per PERCIST 1.0 criteria; For CD70-Negative Lesions (If present at baseline): Must achieve a deep anatomical response, defined as Complete Response (CR) or Partial Response (PR) on CT, maintained for ≥ 12 weeks per RECIST 1.1
- Treatment continuation: not meeting criteria above
Who cannot join
- STEP0: At Treatment Initiation
- Prior systemic therapy for advanced RCC
- Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- Karnofsky Performance Status (KPS) <70%
- Inadequate organ and bone marrow function
- Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) who are clinically stable without progression prior to treatment
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- Concurrent or prior invasive malignancies within the past 5 years, except adequately treated in situ/superficial cancers (e.g., non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix/breast)
- Presence of uncontrolled major comorbidities or recent severe illnesses within 6 months, including but not limited to: uncontrolled hypertension, clinically significant cardiovascular disease, GI disorders with high risk of perforation/fistula, significant hematuria, hematemesis, hemoptysis, major bleeding history, severe active infections (including active HIV, HBV, or HCV), or severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis)
- Life expectancy < 6 months
- Known allergy or hypersensitivity to the CD70 imaging agent or any of its excipients
- Severe hepatic or renal insufficiency, or inability to tolerate PET/CT examination
- Medical/psychiatric/social conditions compromising protocol compliance
- Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment
- STEP1: At 12-Month Evaluation
- Failure to complete 12 months(±1m) of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or disease progression
- Failure or inability to undergo CD70-targeted immuno-PET/CT scan at the 12-month evaluation timepoint
- Unacceptable clinical deterioration or investigator discretion indicating that a treatment holiday is not in the best interest of the patient
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210000
Le Qu, Ph.D., +86 15720625951, septsoul@hotmail.com
- Recruiting
Nanjing First Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210006
Yuzheng Ge, Ph.D., +86 15850675660, geyuzheng@njmu.edu.cn
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Pengfei Shao, Ph.D., +86 13851925825, spf8629@163.com
- Recruiting
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, 211100
Dong Wang, Ph.D., +86 13913935053, wang_dong6028@163.com
- Recruiting
Wuxi No.2 People's Hospital (Jiangnan University Medical Center)
Wuxi, Jiangsu, 214002
Sha Zhu, Ph.D., +86 13961778302, nanyizhusha@126.com
About this study
Official title: A Phase II Trial of CD70-Targeted Immuno-PET/CT-Directed Treatment Holiday for Metastatic Clear Cell Renal Cell Carcinoma With IMDC Favorable or Intermediate Risk
The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1/PD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.
Read the detailed description
Current first-line therapy for advanced renal cell carcinoma (RCC) combines tyrosine kinase inhibitors (TKIs) with immune checkpoint inhibitors (ICIs). Although effective, continuous treatment often results in cumulative toxicities, significant financial burdens, and potential overtreatment for patients.
While intermittent therapy shows promise in maintaining efficacy while mitigating adverse events, conventional CT relies on morphological changes and lacks the sensitivity to distinguish viable tumor tissue from post-treatment fibrosis or necrosis, hindering precise decision-making for treatment cessation. CD70 is a transmembrane protein highly expressed in over 80% of mccRCCs. CD70-targeted immuno-PET/CT, utilizing specific single-domain antibodies, provides a superior molecular imaging tool outperforming FDG-PET and allows for accurate assessment of treatment response to guide intermittent therapy.
In this multi-center, single-arm, phase II trial, mccRCC patients with IMDC favorable or intermediate risk will be enrolled to receive standard first-line ICI plus TKI combination therapy for 12 months (± 1 months) in the absence of disease progression or unacceptable toxicity. After that, patients will be evaluated using both CT (RECIST 1.1) and CD70 immuno-PET/CT (PERCIST criteria). Patients achieving sustained disease control on CT combined with Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET/CT will qualify to pause all systemic treatments and enter treatment holiday. A per-lesion evaluation principle will be applied for baseline heterogeneous lesions. Patients fail to achieve the predefined criteria will continue first-line systemic therapy until disease progression or unacceptable toxicity.
During the treatment holiday, patients will undergo anatomical and molecular monitoring including CT scans every 8-12 weeks and CD70 immuno-PET/CT every 24 weeks. Circulating KIM-1 levels will be longitudinally assessed as an early-warning biomarker. A confirmed clinically meaningful elevation (e.g., ≥ 30% from nadir) may trigger unscheduled or more frequent radiographic evaluations. Original regimen will be immediately restarted upon the occurrence of anatomical progression (RECIST 1.1), metabolic flare (PERCIST), or clinical symptom deterioration.
Peripheral blood, other biological samples, and health-related quality of life questionnaires will be collected at different time points during the trial for future analyses.This study aims to establish a multidimensional decision-making framework to optimize the balance between survival benefits and quality of life in advanced RCC.
- Being tested
- PD-1/PD-L1 ICI + VEGFR-TKI, Treatment pause
- Keywords
- Metastatic Clear Cell Renal Cell Carcinoma, CD70-Targeted Immuno-PET/CT, Treatment Holiday
- Medical subject headings
- Clear-cell metastatic renal cell carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1/PD-L1 ICI + VEGFR-TKIDrug
All participants will receive first-line PD-1/PD-L1 inhibitor + VEGFR-TKI combination therapy for 12 months (±1 month).
Treatment pauseOther
Patients who achieve the predefined criteria after 12 months of treatment will discontinue both drugs and enter a closely monitored treatment holiday. Upon radiographic or clinical progression, the previous systemic therapy will be reintroduced according to the protocol and investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Holiday Strategy | Experimental | Patients with mccRCC who complete 12 months of first-line PD-1/PD-L1 inhibitor plus VEGFR-TKI combination therapy AND achieve the predefined composite response (anatomical CR/PR/SD per RECIST 1.1 AND metabolic CMR/PMR per PERCIST on CD70 immuno-PET/CT) will enter a treatment holiday. Systemic therapy will be suspended, and patients will undergo active surveillance. Receives: Drug: PD-1/PD-L1 ICI + VEGFR-TKI; Other: Treatment pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-free survival (TFS) rate
Defined as the proportion of patients who are alive without having restarted the original therapy at 12 months following discontinuation of the combination therapy.
Measured: 12 months after treatment discontinuation
Secondary outcomes (13)
Overall survival (OS)
Time from enrollment to date of death due to any cause.
Measured: From treatment initiation until 3 years of follow-up
Progression free survival (PFS)
Time from enrollment to first documented disease progression or death, whichever occurs first.
Measured: From treatment initiation until 3 years of follow-up
Overall safety profile
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 criteria.
Measured: From treatment initiation until 3 years of follow-up
Patient-reported outcome (PRO) - Health-related quality of life measured by NCCN FKSI-19
Measured by the NCCN functional assessment of cancer therapy-kidney symptom index (FKSI-19), a 19-item scale assessing treatment-related symptoms and side effects for kidney cancer patients.
Measured: From treatment initiation until 2 years of follow-up
Patient-reported outcome (PRO) - Health-related quality of life measured by EORTC QLQ-C30
Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), a 30-item instrument assessing various domains of physical, emotional, and social functioning for cancer patients.
Measured: From treatment initiation until 2 years of follow-up
Patient-reported outcome (PRO) - General Health status measured by EQ-5D-5L
Measured by the "5-Level EuroQol Group's 5-Dimension" (EQ-5D-5L) questionnaire which comprises the EQ-5D index evaluating health across five dimensions and the EQ-VAS which is a 0-100 visual scale for self-rated overall health.
Measured: From treatment initiation until 2 years of follow-up
Patient-reported outcome (PRO) - Anxiety and depression status measured by HADS
Measured by the Hospital Anxiety and Depression Scale (HADS) which contains 14 items with 7 items measuring anxiety level and 7 items measuring depression level.
Measured: From treatment initiation until 2 years of follow-up
Quality-adjusted life years (QALYs)
The quality-adjusted time without symptoms or toxicity (Q-TWiST) integrates data from patient-reported outcomes (PROs) into survival calculations. It quantifies the utility-weighted sum of mean time across three health states: time with all-cause grade 3/4 toxicity prior to progression, time without grade 3/4 toxicity or symptoms of progression, and time after progression.
Measured: From treatment initiation until 2 years of follow-up
Cost-effectiveness
Measured by the incremental cost-effectiveness ratio (ICER) to provide the ratio of incremental cost per additional quality-adjusted life year (QALY).
Measured: From treatment initiation until 2 years of follow-up
Duration of response (DoR)
Time from first documented complete metabolic response (CMR) or partial metabolic response (PMR) to progression or death.
Measured: From treatment discontinuation until 2 years of follow-up
Distribution of treatment modality after progression
Proportion of participants receiving surveillance, focal treatment, or systemic therapy after disease progression.
Measured: From treatment discontinuation until 2 years of follow-up
Objective response rate (ORR) after restarting treatment
Proportion of participants achieving objective response within 6 months of restarting therapy after progression.
Measured: From treatment discontinuation until 2 years of follow-up
Time to subsequent therapy initiation
Time from treatment discontinuation to the start of subsequent systemic therapy or death, whichever occurs first.
Measured: From treatment discontinuation until 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start16 Jun 2026
- Primary completion10 Aug 2028 (estimated)
- Study completion10 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
- Investigators
- Le Qu, Ph.D., Principal investigator, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615348
- Sponsor's protocol ID
- 2026DZKY-086-01
- Acronym
- PERFUMER-70
- Status last verified
- Aug 2026
- First submitted
- 22 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of CD70-Targeted Immuno-PET/CT-Directed Treatment Holiday for Metastatic Clear Cell Renal Cell Carcinoma With IMDC Favorable or Intermediate Risk
- ClinicalTrials.gov ID
- NCT07615348
- Acronym / sponsor ID
- PERFUMER-70 / 2026DZKY-086-01
- Keywords
- Metastatic Clear Cell Renal Cell Carcinoma, CD70-Targeted Immuno-PET/CT, Treatment Holiday
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 10 Aug 2028 (estimated)
- Study completion
- 10 Aug 2029 (estimated)
- First posted
- 29 May 2026 (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.
The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1/PD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.
Detailed description
Current first-line therapy for advanced renal cell carcinoma (RCC) combines tyrosine kinase inhibitors (TKIs) with immune checkpoint inhibitors (ICIs). Although effective, continuous treatment often results in cumulative toxicities, significant financial burdens, and potential overtreatment for patients.
While intermittent therapy shows promise in maintaining efficacy while mitigating adverse events, conventional CT relies on morphological changes and lacks the sensitivity to distinguish viable tumor tissue from post-treatment fibrosis or necrosis, hindering precise decision-making for treatment cessation. CD70 is a transmembrane protein highly expressed in over 80% of mccRCCs. CD70-targeted immuno-PET/CT, utilizing specific single-domain antibodies, provides a superior molecular imaging tool outperforming FDG-PET and allows for accurate assessment of treatment response to guide intermittent therapy.
In this multi-center, single-arm, phase II trial, mccRCC patients with IMDC favorable or intermediate risk will be enrolled to receive standard first-line ICI plus TKI combination therapy for 12 months (± 1 months) in the absence of disease progression or unacceptable toxicity. After that, patients will be evaluated using both CT (RECIST 1.1) and CD70 immuno-PET/CT (PERCIST criteria). Patients achieving sustained disease control on CT combined with Complete Metabolic Response (CMR) or Partial Metabolic Response (PMR) on CD70 immuno-PET/CT will qualify to pause all systemic treatments and enter treatment holiday. A per-lesion evaluation principle will be applied for baseline heterogeneous lesions. Patients fail to achieve the predefined criteria will continue first-line systemic therapy until disease progression or unacceptable toxicity.
During the treatment holiday, patients will undergo anatomical and molecular monitoring including CT scans every 8-12 weeks and CD70 immuno-PET/CT every 24 weeks. Circulating KIM-1 levels will be longitudinally assessed as an early-warning biomarker. A confirmed clinically meaningful elevation (e.g., ≥ 30% from nadir) may trigger unscheduled or more frequent radiographic evaluations. Original regimen will be immediately restarted upon the occurrence of anatomical progression (RECIST 1.1), metabolic flare (PERCIST), or clinical symptom deterioration.
Peripheral blood, other biological samples, and health-related quality of life questionnaires will be collected at different time points during the trial for future analyses.This study aims to establish a multidimensional decision-making framework to optimize the balance between survival benefits and quality of life in advanced RCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Holiday Strategy | Experimental | Drug: PD-1/PD-L1 ICI + VEGFR-TKI, Other: Treatment pausePatients with mccRCC who complete 12 months of first-line PD-1/PD-L1 inhibitor plus VEGFR-TKI combination therapy AND achieve the predefined composite response (anatomical CR/PR/SD per RECIST 1.1 AND metabolic CMR/PMR per PERCIST on CD70 immuno-PET/CT) will enter a treatment holiday. Systemic therapy will be suspended, and patients will undergo active surveillance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- STEP0: At Treatment Initiation
- Male or female subjects aged ≥ 18 years
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
- Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype
- Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
Key exclusion criteria (17 listed)
- STEP0: At Treatment Initiation
- Prior systemic therapy for advanced RCC
- Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- Karnofsky Performance Status (KPS) <70%
- Inadequate organ and bone marrow function
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 |
|---|---|---|
| PD-1/PD-L1 ICI + VEGFR-TKIAll participants will receive first-line PD-1/PD-L1 inhibitor + VEGFR-TKI combination therapy for 12 months (±1 month). | Drug | Treatment Holiday Strategy |
| Treatment pausePatients who achieve the predefined criteria after 12 months of treatment will discontinue both drugs and enter a closely monitored treatment holiday. Upon radiographic or clinical progression, the previous systemic therapy will be reintroduced according to the protocol and investigator's discretion. | Other | Treatment Holiday Strategy |
Primary outcome
Treatment-free survival (TFS) rate
Time frame: 12 months after treatment discontinuation
Defined as the proportion of patients who are alive without having restarted the original therapy at 12 months following discontinuation of the combination therapy.
13 secondary outcomes
Overall survival (OS)
Time frame: From treatment initiation until 3 years of follow-up
Progression free survival (PFS)
Time frame: From treatment initiation until 3 years of follow-up
Overall safety profile
Time frame: From treatment initiation until 3 years of follow-up
Patient-reported outcome (PRO) - Health-related quality of life measured by NCCN FKSI-19
Time frame: From treatment initiation until 2 years of follow-up
Patient-reported outcome (PRO) - Health-related quality of life measured by EORTC QLQ-C30
Time frame: From treatment initiation until 2 years of follow-up
Patient-reported outcome (PRO) - General Health status measured by EQ-5D-5L
Time frame: From treatment initiation until 2 years of follow-up
Patient-reported outcome (PRO) - Anxiety and depression status measured by HADS
Time frame: From treatment initiation until 2 years of follow-up
Quality-adjusted life years (QALYs)
Time frame: From treatment initiation until 2 years of follow-up
Cost-effectiveness
Time frame: From treatment initiation until 2 years of follow-up
Duration of response (DoR)
Time frame: From treatment discontinuation until 2 years of follow-up
Distribution of treatment modality after progression
Time frame: From treatment discontinuation until 2 years of follow-up
Objective response rate (ORR) after restarting treatment
Time frame: From treatment discontinuation until 2 years of follow-up
Time to subsequent therapy initiation
Time frame: From treatment discontinuation until 2 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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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.
Le Qu, Ph.D. principal investigator
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1/PD-L1 ICI + VEGFR-TKI and Treatment pause in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Jinling Hospital, China at 5 sites 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 23 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Le Qu, Ph.D. (+86 15720625951, septsoul@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-free survival (TFS) rate (time frame: 12 months after treatment discontinuation). 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 11 Aug 2026.