Renal Cell Carcinoma Stage IPhase 2NCT06730672
An Exploratory Study on the Failure of Immunotherapy With Vorolanib Combined With Everolimus
A Phase 2 study testing Vorolanib combined with Everolimus Formation in people with Renal Cell Carcinoma Stage I, run by Sun Yat-sen University at 2 sites in China.
Trial summary
This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Vorolanib 200mg PO.QD combined with everolimus 5mg QD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma Stage I
- What is being tested?
- Vorolanib combined with Everolimus Formation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 30 Dec 2025to 27 Dec 2028
- 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
- Clear cell carcinoma of the kidney is confirmed by pathology (histology or cytology);
- Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor and failed treatment;
- Not less than 3 weeks after receiving the last systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, biotherapy or endocrine therapy), Or not less than 5 half-lives since the last systemic antitumor treatment; And treatment-related toxicity was recovered to meet the laboratory test requirements for this study;
- ECOG score ≤ 1;
- Over 18 years old, and less than or equal to 75 years old; a life expectancy of more than 12 weeks
- According to RECIST 1.1 criteria: at least one measurable lesion;
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- Organ function levels must meet the following requirements:
- Bone marrow: blood test results must show hemoglobin ≥ 80 g/L, platelets ≥ 90 x 10^9/L, absolute neutrophil count ≥ 1.5 x 10^9/L; Liver: serum bilirubin ≤ 1.5 times the upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (if there is liver metastasis, AST and ALT ≤ 5 times the upper limit of normal are allowed); Serum creatinine < 1.5 times the upper limit of normal; Urinary protein ≤ 2+, if urinary protein > 2+, a 24-hour urine protein test must be collected with a total amount ≤ 2 grams; Well-controlled hypertensive patients; Echocardiogram shows left ventricular ejection fraction greater than 40%;
- For women of childbearing potential, the serum pregnancy test must be negative within 7 days prior to randomization;
- All enrolled subjects (regardless of gender) must use effective barrier contraceptive methods throughout the treatment period and for 4 weeks after treatment ends;
- Subjects must have the ability to understand and voluntarily sign the informed consent form, and the signing of the informed consent must occur prior to any study procedure.
Who cannot join
- Previously only received single-drug targeted drug therapy against VEGF/VEGFR or mTOR；
- Subjects currently receiving antitumor therapy (e.g., chemotherapy, radiation therapy, immunotherapy, biotherapy, hormone therapy, surgery, and/or tumor embolization, but excluding local radiation therapy for bone metastases) may be enrolled if they have a half-life of 5 years after the end of drug therapy；
- Progression after previous mTOR therapy (monotherapy or combination)；
- Conditions of the subjects' organ systems:
- Presence of significant pleural effusion or ascites with clinical symptoms requiring symptomatic treatment; brain metastases, or epidural metastases;
- Subjects who have had other malignancies within the past 5 years (excluding non-melanoma skin cancer, cervical carcinoma in situ, or successfully treated basal cell carcinoma or squamous cell carcinoma);
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- Any uncontrolled clinical issues, including but not limited to, persistent or active infections, uncontrolled diabetes, decompensated liver cirrhosis;
- Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting, New York Heart Association (NYHA) class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or rest leg claudication occurring within the 12 months prior to randomization;
- Deep vein thrombosis or pulmonary embolism occurring within 6 months prior to randomization;
- Any major surgery performed within 4 weeks prior to randomization;
- A clear history of mental illness that hinders understanding of the informed consent and compliance with the study protocol;
- Patients infected with the human immunodeficiency virus (HIV);
- Active autoimmune diseases requiring systemic treatment in the past two years (such as treatment with disease-modifying drugs, corticosteroids, or immunosuppressants);
- Subjects known to be allergic to similar drugs;
- Any condition affecting the subject's ability to swallow medication or any condition affecting the absorption or pharmacokinetics of the investigational drug, including any history of gastrointestinal resection or surgery;
- The presence of severe pulmonary disease, history of asthma or COPD, and pulmonary function tests indicating moderate to severe impairment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
xu zhi Pan, +860287343009
juan li Jiang lijuan, M.D, +8613430246641, jianglij@sysucc.org.cn
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
Official title: Efficacy and Safety of Vorolanib Combined With Everolimus After Immunotherapy Failure in Advanced Renal Carcinoma
This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Vorolanib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.
Read the detailed description
The participant must have received no more than two kinds of tyrosine kinase inhibitors (TKIs) medications (excluding mTOR inhibitors) and one type of immune checkpoint inhibitor treatment, with treatment failure in systemic antitumor therapy. Additionally, the participant must have completed the last systemic antitumor treatment ( chemotherapy,radiotherapy, targeted therapy, biological therapy, or endocrine therapy) at least 3 weeks prior, or at least 5 half-lives since the last systemic antitumor treatment. Furthermore, any treatment-related toxicities must have resolved to meet the laboratory test requirements for this trial.
- Conditions
- Renal Cell Carcinoma Stage I
- Being tested
- Vorolanib combined with Everolimus Formation
- Keywords
- Renal Cell Carcinoma, Failure in immune checkpoint inhibitors renal cell carcinoma
- 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.
Vorolanib combined with Everolimus FormationDrug
Also called Single-arm
Vorolanib 200mg once daily and Everolimus 5mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Volonib combined with Everolimus Formation | Experimental | Volonib 200mg once daily and Everolimus 5mg once daily Receives: Drug: Vorolanib combined with Everolimus Formation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The definition of Progression-free survival（PFS） is the time from the date of first dose until the first observation of disease progression (PD) (as determined by radiographic assessment) or death (whichever occurs first).
Measured: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Secondary outcomes (5)
Overall survival
Overall survival（OS） was defined as the time from the date of first dose to the date of death from any cause.
Measured: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Objective response rate
The Objective response rate（ORR） was defined as the proportion of patients with a best overall response of complete or partial response.
Measured: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Disease control rate
Disease control rate（DCR）was defined the proportion of patients with complete response, partial response, and stable disease.
Measured: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Duration of response
Duration of response (DOR)defined as the time from first documented response, PR or CR, to progressive disease [PD] or death; patients who neither progressed nor died were censored on the date of their last radiographic tumor assessment.
Measured: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Dynamic changes in ctDNA levels and alterations in the ctDNA mutation profile
In this study, blood samples were collected for ctDNA testing.
Measured: In this study, a maximum of six blood samples were collected for ctDNA testing, specifically before treatment, and after drug treatment at 2 months, 4 months, 6 months, 8 months, and at the time of PD (progressive disease) occurrence up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start30 Dec 2025
- Primary completion27 Dec 2027 (estimated)
- Study completion27 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma Stage IStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
- Investigators
- Fangjian F Zhou, M.D, Principal investigator, 中山大学肿瘤防治中心
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730672
- Sponsor's protocol ID
- B2024-659-01
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vorolanib Combined With Everolimus After Immunotherapy Failure in Advanced Renal Carcinoma
- ClinicalTrials.gov ID
- NCT06730672
- Acronym / sponsor ID
- B2024-659-01
- Conditions
- Renal Cell Carcinoma Stage I
- Keywords
- Renal Cell Carcinoma, Failure in immune checkpoint inhibitors renal cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 27 Dec 2027 (estimated)
- Study completion
- 27 Dec 2028 (estimated)
- First posted
- 12 Dec 2024 (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.
This single-arm exploratory study included patients with renal clear cell carcinoma who had previously received one type of immunotherapy and failed. The specific regimen was Vorolanib 200mg PO.QD combined with everolimus 5mg QD. 80 patients were planned to continue treatment until PD, toxicity became intolerable, patient withdrawal was informed, or medication had to be discontinued. Collect patient medication information and disease efficacy evaluation, adverse reactions. In this study, blood samples were collected 0-4 weeks before treatment, 2 months, 4 months, 6 months, 8 months of drug treatment, and at the time of PD progression for ctDNA detection.
Detailed description
The participant must have received no more than two kinds of tyrosine kinase inhibitors (TKIs) medications (excluding mTOR inhibitors) and one type of immune checkpoint inhibitor treatment, with treatment failure in systemic antitumor therapy. Additionally, the participant must have completed the last systemic antitumor treatment ( chemotherapy,radiotherapy, targeted therapy, biological therapy, or endocrine therapy) at least 3 weeks prior, or at least 5 half-lives since the last systemic antitumor treatment. Furthermore, any treatment-related toxicities must have resolved to meet the laboratory test requirements for this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volonib combined with Everolimus Formation | Experimental | Drug: Vorolanib combined with Everolimus FormationVolonib 200mg once daily and Everolimus 5mg once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clear cell carcinoma of the kidney is confirmed by pathology (histology or cytology);
- Have received systemic anti-tumor therapy with no more than 2 targeted drugs (excluding mTOR inhibitors) and 1 immune checkpoint inhibitor and failed treatment;
- Not less than 3 weeks after receiving the last systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy, biotherapy or endocrine therapy), Or not less than 5 half-lives since the last systemic antitumor treatment; And treatment-related toxicity was recovered to meet the laboratory test requirements for this study;
- ECOG score ≤ 1;
- Over 18 years old, and less than or equal to 75 years old; a life expectancy of more than 12 weeks
Key exclusion criteria (16 listed)
- Previously only received single-drug targeted drug therapy against VEGF/VEGFR or mTOR；
- Subjects currently receiving antitumor therapy (e.g., chemotherapy, radiation therapy, immunotherapy, biotherapy, hormone therapy, surgery, and/or tumor embolization, but excluding local radiation therapy for bone metastases) may be enrolled if they have a half-life of 5 years after the end of drug therapy；
- Progression after previous mTOR therapy (monotherapy or combination)；
- Conditions of the subjects' organ systems:
- Presence of significant pleural effusion or ascites with clinical symptoms requiring symptomatic treatment; brain metastases, or epidural metastases;
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 |
|---|---|---|
| Vorolanib combined with Everolimus FormationAlso: Single-armVorolanib 200mg once daily and Everolimus 5mg once daily | Drug | Volonib combined with Everolimus Formation |
Primary outcome
Progression-free survival
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
The definition of Progression-free survival（PFS） is the time from the date of first dose until the first observation of disease progression (PD) (as determined by radiographic assessment) or death (whichever occurs first).
5 secondary outcomes
Overall survival
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Objective response rate
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Disease control rate
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Duration of response
Time frame: From date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death
Dynamic changes in ctDNA levels and alterations in the ctDNA mutation profile
Time frame: In this study, a maximum of six blood samples were collected for ctDNA testing, specifically before treatment, and after drug treatment at 2 months, 4 months, 6 months, 8 months, and at the time of PD (progressive disease) occurrence up to 36 months
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 22 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Fangjian F Zhou, M.D principal investigator
中山大学肿瘤防治中心
2 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 Vorolanib combined with Everolimus Formation in people with Renal Cell Carcinoma Stage I, run by Sun Yat-sen University at 2 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 11 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 pei P Dong, M.D (+8613512738496, dongpei@sysucc.org.cn), 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 date of initiate treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months until disease progression or death). 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 22 Oct 2026.