RCCNCT07324876
A Multicenter Real-World Study on TKI Therapy After Progression on First-Line TKI/IO Therapy or TKI/IO Therapy After Progression on First-Line TKI in Chinese Patients With Metastatic Renal Cell Carcinoma (mRCC)
An observational study of RCC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
TKI monotherapy or TKI/IO combination therapy is the standard first-line treatment for low- and intermediate-risk advanced renal cell carcinoma (RCC). In clinical practice, after the failure of first-line therapy, sequential treatment is often selected based on the initial regimen, with options including TKI/IO… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- RCC
- How many people
- 860 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 31 Dec 2028
- Phase
- Observational
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: Renal cell carcinoma
Who may be able to join
- Subjects with histologically confirmed unresectable metastatic renal cell carcinoma (mRCC) will be included in the study. Previous nephrectomy or metastasectomy is allowed, but no prior systemic anticancer therapy targeting RCC is permitted.
- Classified as low- or intermediate-risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.
- Male or female subjects aged 18 years or older at the time of signing the informed consent form.
- Defined as Chinese ethnicity, with both biological parents and all four biological grandparents being of Chinese descent.
- Patients who progressed or were intolerant to first-line TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.) and subsequently received TKI/IO therapy (including axitinib/ lenvatinib/ cabozantinib combined with toripalimab/ tislelizumab/ pembrolizumab/ sintilimab/ nivolumab, etc.).
- Patients who progressed or were intolerant to first-line TKI/IO therapy (including axitinib/ lenvatinib/ cabozantinib combined with toripalimab/ tislelizumab/ pembrolizumab/ sintilimab/ nivolumab, etc.) and subsequently received TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.).
- Karnofsky Performance Status (KPS) ≥ 70% within 10 days prior to the first dose of treatment.
- Adequate organ function as evidenced by laboratory values: ANC ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 10.0 g/dL or ≥ 6.2 mmol/L; CrCl ≥ 30 mL/min; AST and ALT ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; and INR or PT ≤ 1.5 × ULN.
Who cannot join
- Requiring intermittent oxygen supplementation at rest, or long-term oxygen therapy.
- Clinically significant cardiovascular disease within 6 months prior to the first dose of study intervention.
- Severe active, non-healing wound, ulcer, or fracture.
- Use of colony-stimulating factors (e.g., G-CSF, GM-CSF), recombinant erythropoietin (EPO), or blood transfusion within 28 days prior to the first dose of study intervention.
- Inability to swallow oral medications or a history of, or current evidence of, gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function, or other conditions that, in the investigator's opinion, may significantly alter the absorption or metabolism of oral study interventions.
- Severe hypersensitivity reactions to TKI drugs, IO drugs, and/or any excipients.
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- Diagnosis of immunodeficiency or use of long-term systemic corticosteroids (daily dose exceeding 10 mg prednisone or equivalent) or any form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Diagnosis of another malignancy (excluding RCC treated by nephrectomy and/or metastasectomy) that is currently progressing or required active treatment in the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have undergone potentially curative treatment are eligible.
- Active autoimmune disease requiring systemic treatment (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic treatment and is allowed.
- History of or current (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or current pneumonitis/interstitial lung disease.
- Active infection requiring systemic treatment.
- Known history of HIV infection, hepatitis B (defined as HBsAg reactive), or active hepatitis C virus (defined as detectable HCV RNA [qualitative]). Note: Testing for HIV, HBV, or HCV is not required unless mandated by local health regulations.
- Any prior or current condition, treatment, laboratory abnormality, or other circumstance that may interfere with the study results, affect the subject's ability to complete the study, or, in the investigator's opinion, make the subject unsuitable for participation or unlikely to benefit from the study.
- Known psychiatric or substance abuse disorders that would interfere with the subject's ability to comply with study requirements
- History of prior allogeneic tissue/solid organ transplantation.
- If the subject is a non-pregnant and non-lactating female, the subject must agree to use highly effective (failure rate <1% per year) and low-dependency contraceptive methods during treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
TKI monotherapy or TKI/IO combination therapy is the standard first-line treatment for low- and intermediate-risk advanced renal cell carcinoma (RCC). In clinical practice, after the failure of first-line therapy, sequential treatment is often selected based on the initial regimen, with options including TKI/IO therapy or TKI therapy. In the real-world setting of low- and intermediate-risk advanced RCC in China, which sequential treatment strategy-TKI/IO-TKI or TKI-TKI/IO-provides greater survival benefits for patients? This study aims to compare the efficacy, safety, and cost-effectiveness of TKI/IO-TKI sequential therapy versus TKI-TKI/IO sequential therapy in real-world low- and intermediate-risk mRCC patients. The objective is to accurately identify the optimal patient subgroups for each treatment strategy, optimize treatment plans, improve patient quality of life, reduce healthcare costs, provide guidance and reference for the clinical management of low- and intermediate-risk mRCC patients, and contribute to the refinement and updating of related Chinese treatment guidelines.
- Conditions
- RCC
- Keywords
- tyrosine kinase inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| the TKI/IO-TKI sequential treatment group | Not described | |
| the TKI-TKI/IO sequential treatment group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS2
defined as the time from the initiation of first-line treatment to disease progression on second-line therapy or death from any cause in a real-world setting
Measured: 1year
Secondary outcomes (5)
1L-rwPFS
Evaluate the real-world progression-free survival of first-line therapy (1L-rwPFS) for both cohorts
Measured: 1year
2L-rwPFS
Evaluate the real-world progression-free survival of second-line therapy (2L-rwPFS) for both cohorts
Measured: 1year
OS
the overall survival
Measured: 1year
ORR
Assess the objective response rate (ORR) of primary and metastatic lesions based on RECIST 1.1 criteria for both cohorts
Measured: 1year
saftey
Evaluate the safety profiles of the treatments in both cohorts
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RCCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324876
- Sponsor's protocol ID
- E20250713
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2025
- Last updated
- 8 Jan 2026
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Real-World Study on TKI Therapy After Progression on First-Line TKI/IO Therapy or TKI/IO Therapy After Progression on First-Line TKI in Chinese Patients With Metastatic Renal Cell Carcinoma (mRCC)
- ClinicalTrials.gov ID
- NCT07324876
- Acronym / sponsor ID
- E20250713
- Conditions
- RCC
- Keywords
- tyrosine kinase inhibitors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 860 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 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.
TKI monotherapy or TKI/IO combination therapy is the standard first-line treatment for low- and intermediate-risk advanced renal cell carcinoma (RCC). In clinical practice, after the failure of first-line therapy, sequential treatment is often selected based on the initial regimen, with options including TKI/IO therapy or TKI therapy. In the real-world setting of low- and intermediate-risk advanced RCC in China, which sequential treatment strategy-TKI/IO-TKI or TKI-TKI/IO-provides greater survival benefits for patients? This study aims to compare the efficacy, safety, and cost-effectiveness of TKI/IO-TKI sequential therapy versus TKI-TKI/IO sequential therapy in real-world low- and intermediate-risk mRCC patients. The objective is to accurately identify the optimal patient subgroups for each treatment strategy, optimize treatment plans, improve patient quality of life, reduce healthcare costs, provide guidance and reference for the clinical management of low- and intermediate-risk mRCC patients, and contribute to the refinement and updating of related Chinese treatment guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the TKI/IO-TKI sequential treatment group | – | – |
| the TKI-TKI/IO sequential treatment group | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Renal cell carcinoma
Key inclusion criteria (8 listed)
- Subjects with histologically confirmed unresectable metastatic renal cell carcinoma (mRCC) will be included in the study. Previous nephrectomy or metastasectomy is allowed, but no prior systemic anticancer therapy targeting RCC is permitted.
- Classified as low- or intermediate-risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.
- Male or female subjects aged 18 years or older at the time of signing the informed consent form.
- Defined as Chinese ethnicity, with both biological parents and all four biological grandparents being of Chinese descent.
- Patients who progressed or were intolerant to first-line TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.) and subsequently received TKI/IO therapy (including axitinib/ lenvatinib/ cabozantinib combined with toripalimab/ tislelizumab/ pembrolizumab/ sintilimab/ nivolumab, etc.).
Key exclusion criteria (16 listed)
- Requiring intermittent oxygen supplementation at rest, or long-term oxygen therapy.
- Clinically significant cardiovascular disease within 6 months prior to the first dose of study intervention.
- Severe active, non-healing wound, ulcer, or fracture.
- Use of colony-stimulating factors (e.g., G-CSF, GM-CSF), recombinant erythropoietin (EPO), or blood transfusion within 28 days prior to the first dose of study intervention.
- Inability to swallow oral medications or a history of, or current evidence of, gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function, or other conditions that, in the investigator's opinion, may significantly alter the absorption or metabolism of oral study interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PFS2
Time frame: 1year
defined as the time from the initiation of first-line treatment to disease progression on second-line therapy or death from any cause in a real-world setting
5 secondary outcomes
1L-rwPFS
Time frame: 1year
2L-rwPFS
Time frame: 1year
OS
Time frame: 1year
ORR
Time frame: 1year
saftey
Time frame: 1year
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 8 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RCC, run by Tianjin Medical University Cancer Institute and 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 8 inclusion and 16 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: opening soon, as of the sponsor's last update on 8 Jan 2026. 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?
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 xin yao, Ph.D (+86-02223340123, yaoxin1969@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS2 (time frame: 1year). 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 8 Jan 2026.