VorolanibPhase 2NCT07386158
Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC
A Phase 2 study testing Pucotenlimab combination with Vorolanib in people with Vorolanib and Clear Cell Renal Cell Carcinoma (ccRCC), run by Sun Yat-sen University at 1 site in China.
Trial summary
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Vorolanib, Clear Cell Renal Cell Carcinoma (ccRCC), Neoadjuvant Therapy
- What is being tested?
- Pucotenlimab combination with Vorolanib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 31 Dec 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign a written informed consent form (ICF).
- Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
- Expected survival period ≥ 3 months.
- Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
- ECOG score 0 or 1
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- The patient is willing to undergo kidney preservation surgery
- Preoperative assessment of healthy kidney GFR<60 ml/min through renal dynamic imaging
- There are indications for kidney preservation surgery, but the surgery is difficult [① 4-7cm tumor located at the renal hilum or endogenous ≥ 75% (T1bN0M0); ② Tumors larger than 7cm (T2N0M0)] 9. There should be at least one measurable lesion (according to mRECIST v1.1 criteria) that is suitable for repeated and accurate measurements.
- Good organ function, laboratory test results during the screening period meet the following criteria:
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- Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment):
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); b. Platelet count (PLT) ≥ 100 × 109/L (100000/mm3); c. Hemoglobin (HB) ≥ 90 g/L;
- Liver:
- Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 × ULN; For subjects with liver metastasis, AST and ALT ≤ 5 × ULN
- Serum albumin (ALB) ≥ 28g/L
- Coagulation function:
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN 11. The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
Who cannot join
- Renal vein cancer thrombus
- Diffuse tumor growth, with no clear boundary from normal renal parenchyma
- General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery
- Have serious cardiovascular and cerebrovascular diseases, uncontrollable
- hypertension and diabetes
- Patients who have long-term use of immunosuppressants after organ transplantation
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- Patients who are currently using immunosuppressive drugs
- Patients with clear infection or fever
- Patients with T-cell lymphoma and myeloma
- Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months
- Metastatic renal cell carcinoma.
- Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug
- Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
- Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.
- Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.
- Known history of mental illness, drug abuse, alcoholism, or drug use.
- Pregnant or lactating women.
- Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.
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
Sun Yat-sen University Cancer Center
Guangzhou, Other (Non U.s.), 0755
Zhiling Zhang, M.D, +862087342318, zhangzhl@sysucc.org.cn
Yulu Peng, M.D, +862087342318, pengyl1@sysucc.org.cn
About this study
Official title: Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)
- Being tested
- Pucotenlimab combination with Vorolanib
- Keywords
- Vorolanib, Clear Cell Renal Cell Carcinoma (ccRCC), Neoadjuvant therapy
- 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.
Pucotenlimab combination with VorolanibDrug
3.7.1 Vorolanib Vorolanib 200mg PO QD, taken with or without food. 3.7.2 Pucotenlimab Intravenous infusion of 200mg of Pucotenlimab (injection), once every 3 weeks, as one treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Pucotenlimab combination with Vorolanib as neoadjuvant therapy | Experimental | Vorolanib Treatment Vorolanib 200mg orally once daily, with or without food.Intravenous Infusion of Pucotenlimab(Injection) Infuse Pucotenlimab at a dose of 200mg intravenously every three weeks, constituting one treatment cycle, the maximum duration of treatment should not exceed 4 cycles.Perform imaging evaluation after 2 cycles, including renal CT plain scan+enhancement, measurement of tumor volume, and evaluation of ORR. If PD is detected in the first imaging assessment, the study will be terminated. According to the current diagnosis and treatment routine, communicate with the patient about the follow-up treatment plan:Radical nephrectomy; Utilization of other targeted therapies; Combination targeted therapy with immunotherapy. If the tumor shrinks significantly and the surgeon evaluates that partial nephrectomy can be safely performed, drug therapy should be stopped and partial nephrectomy should be performed; otherwise, continue treatment to 4 cycles before surgery. Receives: Drug: Pucotenlimab combination with Vorolanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Measured: Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start10 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VorolanibStudies 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
- 21 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386158
- Sponsor's protocol ID
- B2025-041-01
- Status last verified
- Oct 2025
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 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 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT07386158
- Acronym / sponsor ID
- B2025-041-01
- Keywords
- Vorolanib, Clear Cell Renal Cell Carcinoma (ccRCC), Neoadjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Feb 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.
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (T1b with an endophytic component ≥75% or T2)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pucotenlimab combination with Vorolanib as neoadjuvant therapy | Experimental | Drug: Pucotenlimab combination with VorolanibVorolanib Treatment Vorolanib 200mg orally once daily, with or without food.Intravenous Infusion of Pucotenlimab(Injection) Infuse Pucotenlimab at a dose of 200mg intravenously every three weeks, constituting one treatment cycle, the maximum duration of treatment should not exceed 4 cycles.Perform imaging evaluation after 2 cycles, including renal CT plain scan+enhancement, measurement of tumor volume, and evaluation of ORR. If PD is detected in the first imaging assessment, the study will be terminated. According to the current diagnosis and treatment routine, communicate with the patient about the follow-up treatment plan:Radical nephrectomy; Utilization of other targeted therapies; Combination targeted therapy with immunotherapy. If the tumor shrinks significantly and the surgeon evaluates that partial nephrectomy can be safely performed, drug therapy should be stopped and partial nephrectomy should be performed; otherwise, continue treatment to 4 cycles before surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Voluntarily sign a written informed consent form (ICF).
- Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
- The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1.
- Expected survival period ≥ 3 months.
- Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
Key exclusion criteria (18 listed)
- Known history of mental illness, drug abuse, alcoholism, or drug use.
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 |
|---|---|---|
| Pucotenlimab combination with Vorolanib3.7.1 Vorolanib Vorolanib 200mg PO QD, taken with or without food. 3.7.2 Pucotenlimab Intravenous infusion of 200mg of Pucotenlimab (injection), once every 3 weeks, as one treatment cycle. | Drug | Pucotenlimab combination with Vorolanib as neoadjuvant therapy |
Primary outcome
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
Time frame: Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatment
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 4 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Vorolanib
RecruitingPhase 2
An Exploratory Study on the Failure of Immunotherapy With Vorolanib Combined With Everolimus
Renal Cell Carcinoma Stage I
RecruitingPhase 1
Drug-Drug Interaction Study of Vorolanib Tablets in Healthy Participants
DDI (Drug-Drug Interaction)
RecruitingPhase 1
Pharmacokinetic Study of Vorolanib Tablets in Trial Participants With Hepatic Impairment
Hepatic Impairment (HI)
RecruitingObservational study
Vorolanib in the Second-line Treatment of Patients With Unresectable or Metastatic Renal Cell Carcinoma
Neoplasms, Kidney Neoplasms
Not yet recruitingPhase 3
A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI
Renal Cell Carcinoma (RCC)
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?
A Phase 2 study testing Pucotenlimab combination with Vorolanib in people with Vorolanib and Clear Cell Renal Cell Carcinoma (ccRCC), run by Sun Yat-sen University 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 19 inclusion and 18 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 4 Feb 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.
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 Zhiling Zhang, M.D (+862087342318, zhangzhl@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) based on RECIST 1.1 criteria. (time frame: Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatment). 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 4 Feb 2026.