NeoplasmsNCT06676527
Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
An observational study of Neoplasms and Kidney Neoplasms, run by Jinling Hospital, China at 1 site in China.
Trial summary
This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasms, Kidney Neoplasms, Urologic Neoplasms
- What is being tested?
- Follow-up study of the treated cohort
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 1 Sep 2026
- How long will I take part?
- 12 Weeks
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects clinically diagnosed with advanced unresectable or metastatic renal cell carcinoma. After receiving at least one systemic therapy (including TKIs or TKIs combined with ICIs, including but not limited to axitinib, sunitinib, sorafenib, pembrolizumab, etc.), subjects reach PD as assessed by RECIST v1.1 and switch to second-line treatment options including vorolanib.
Who may be able to join
- Subjects have fully understood and voluntarily signed the informed consent form (ICF);
- 18-80 years old (at the time of signing the informed consent); Both men and women; ECOG PS score: 0-1;
- Renal cell carcinoma with clear cell components confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components;
- According to RECIST (version 1.1), there are targets that are considered to be observable;
- The main organs function well.
Who cannot join
- A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);
- Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy within 4 weeks prior to the initial study;
- Had major surgery within 4 weeks prior to initial study dosing (as judged by the investigator) or was in recovery;
- A history of severe drug allergy, including but not limited to antibody drugs;
- Patients with contraindications for immunotherapy restart;
- A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation may require long-term adrenal corticosteroid therapy. Patients with thyroid, suprarenal, or hypopituitarism that can be controlled by hormone replacement therapy alone, type 1 diabetes mellitus, and psoriasis or vitiligo that do not require systemic treatment are eligible to participate in this study;
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- Toxicity did not resolve after previous antitumor therapy, i.e., regression to baseline, NCI-CTCAE 5.0 level 0-1 (except for alopecia), or levels specified in inclusion/exclusion criteria. Irreversible toxicity (e.g., hearing loss) that is not reasonably expected to be aggravated by the drug under study may be included in the study;
- Have central nervous system metastases and/or cancerous meningitis;
- Known history of clinically significant liver disease, including those infected with viral hepatitis activity;
- Patients with uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc. (Patients with no need to drain effusion or no significant increase in effusion after 3 days of stopping drainage could be included);
- Patients with any severe and/or uncontrolled disease;
- Renal failure requires hemodialysis or peritoneal dialysis;
- Have or have a suspected active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.;
- History of live attenuated vaccine vaccination within 4 weeks prior to the initial study or expected live attenuated vaccine vaccination during the study period;
- Those who have a history of psychotropic drug abuse and cannot abstain or have a history of mental disorders;
- Other severe, acute, or chronic medical or psychiatric conditions or laboratory abnormalities, as determined by the investigator, that may increase the risks associated with study participation or that may interfere with the interpretation of the study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling Hospital
Nanjing, Jiangsu, 401520
Le Qu, M. D., +86 15123894157, septsoul@hotmail.com
About this study
Official title: An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.
Read the detailed description
This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted. Vorolanib is a new generation of multi-target kinase inhibitors with a new chemical structure, which can inhibit tumor angiogenesis and growth, and is used in the treatment of various cancers. This multicenter, single-arm, open-labelled observational study is designed to include patients who meet the requirements for using vorolanib as a second-line treatment for renal cell carcinoma. For those patients who have reached the end point of the study, survival data during treatment with vorolanib is obtained for retrospective analysis. The patients who are still on treatment with vorolanib are followed up closely and survival data is obtained for prospective analysis. After summarizing the results of retrospective and prospective studies, relevant efficacy and safety conclusions will be drawn.
- Conditions
- Neoplasms, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Female Urogenital Diseases, Male Urogenital Diseases
- Being tested
- Follow-up study of the treated cohort
- Keywords
- observational study, clear cell Renal Cell Carcinoma, TKIs
- Medical subject headings
- Neoplasms, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Female Urogenital Diseases, Male Urogenital Diseases, Urogenital Diseases, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up study of the treated cohortOther
For those patients who have reached the end point of the study, survival data during treatment with vorolanib is obtained for retrospective analysis. The patients who are still on treatment with vorolanib are followed up closely and survival data is obtained for prospective analysis. After summarizing the results of retrospective and prospective studies, relevant efficacy and safety conclusions will be drawn.
| Study group | Role | What they receive |
|---|---|---|
| Experimental cohort. | Subjects who progressed after first-line treatment and switched to second-line treatment regimens including vorolanib. The first-line treatment which patients received can be other tyrosine kinase inhibitors (TKIs) or TKIs combined with immunotherapy drugs. Provided vorolanib is contained in the second-line regimen, the patient then can be considered for inclusion in the study. Receives: Other: Follow-up study of the treated cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Measured: From enrollment to the end of treatment at 12 weeks.
Treatment Related Adverse Events (TRAEs)
Measured: From enrollment to up to 90 days after treatment at 12 weeks or reported.
Secondary outcomes (3)
Overall Survival (OS)
Measured: From enrollment to the end of treatment at 12 weeks.
Objective Response Rate (ORR)
Measured: From enrollment to the end of treatment at 12 weeks.
Disease Control Rate (DCR)
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 39 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Qu, Jinling Hospital, China
- Investigators
- Yuxiu Liu, M. D., Study chair, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676527
- Sponsor's protocol ID
- 2024DZKY-074-02
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Efficacy and Safety of Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06676527
- Acronym / sponsor ID
- 2024DZKY-074-02
- Conditions
- Neoplasms, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Female Urogenital Diseases, Male Urogenital Diseases
- Keywords
- observational study, clear cell Renal Cell Carcinoma, TKIs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 6 Nov 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 is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.
Detailed description
This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted. Vorolanib is a new generation of multi-target kinase inhibitors with a new chemical structure, which can inhibit tumor angiogenesis and growth, and is used in the treatment of various cancers. This multicenter, single-arm, open-labelled observational study is designed to include patients who meet the requirements for using vorolanib as a second-line treatment for renal cell carcinoma. For those patients who have reached the end point of the study, survival data during treatment with vorolanib is obtained for retrospective analysis. The patients who are still on treatment with vorolanib are followed up closely and survival data is obtained for prospective analysis. After summarizing the results of retrospective and prospective studies, relevant efficacy and safety conclusions will be drawn.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental cohort. | – | Other: Follow-up study of the treated cohortSubjects who progressed after first-line treatment and switched to second-line treatment regimens including vorolanib. The first-line treatment which patients received can be other tyrosine kinase inhibitors (TKIs) or TKIs combined with immunotherapy drugs. Provided vorolanib is contained in the second-line regimen, the patient then can be considered for inclusion in the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects clinically diagnosed with advanced unresectable or metastatic renal cell carcinoma. After receiving at least one systemic therapy (including TKIs or TKIs combined with ICIs, including but not limited to axitinib, sunitinib, sorafenib, pembrolizumab, etc.), subjects reach PD as assessed by RECIST v1.1 and switch to second-line treatment options including vorolanib.
Key inclusion criteria (5 listed)
- Subjects have fully understood and voluntarily signed the informed consent form (ICF);
- 18-80 years old (at the time of signing the informed consent); Both men and women; ECOG PS score: 0-1;
- Renal cell carcinoma with clear cell components confirmed histologically or cytopathologically, including unresectable or recurrent metastatic renal cell carcinoma dominated by clear cell components;
- According to RECIST (version 1.1), there are targets that are considered to be observable;
- The main organs function well.
Key exclusion criteria (16 listed)
- A history of malignancies other than the disease studied within the past 5 years, other than malignancies that are expected to be cured with treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or breast ductal carcinoma in situ treated with radical surgery);
- Systemic treatment with other antitumor agents, including targeted agents, immunotherapy agents and their combination regimens (eligible for inclusion after 5 half-lives), local antitumor therapy, or clinical investigational drug or device therapy within 4 weeks prior to the initial study;
- Had major surgery within 4 weeks prior to initial study dosing (as judged by the investigator) or was in recovery;
- A history of severe drug allergy, including but not limited to antibody drugs;
- Patients with contraindications for immunotherapy restart;
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 |
|---|---|---|
| Follow-up study of the treated cohortFor those patients who have reached the end point of the study, survival data during treatment with vorolanib is obtained for retrospective analysis. The patients who are still on treatment with vorolanib are followed up closely and survival data is obtained for prospective analysis. After summarizing the results of retrospective and prospective studies, relevant efficacy and safety conclusions will be drawn. | Other | Experimental cohort. |
Primary outcome
Progression Free Survival (PFS)
Time frame: From enrollment to the end of treatment at 12 weeks.
Treatment Related Adverse Events (TRAEs)
Time frame: From enrollment to up to 90 days after treatment at 12 weeks or reported.
3 secondary outcomes
Overall Survival (OS)
Time frame: From enrollment to the end of treatment at 12 weeks.
Objective Response Rate (ORR)
Time frame: From enrollment to the end of treatment at 12 weeks.
Disease Control Rate (DCR)
Time frame: From enrollment to the end of treatment at 12 weeks.
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 5 Dec 2025.
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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.
Yuxiu Liu, M. D. study chair
Jinling Hospital, China
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 Neoplasms and Kidney Neoplasms, run by Jinling Hospital, China 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 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 5 Dec 2025. 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 Le Qu, M. 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?
Progression Free Survival (PFS) (time frame: From enrollment to the end of treatment at 12 weeks.). The study lists 2 primary outcomes in all. 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 5 Dec 2025.