Localized Clear Cell Renal Cell CarcinomaPhase 2PLS-NEO-RCCNCT07922915
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
A Phase 2 study testing Pucotenlimab, Lenvatinib and Stereotactic Body Radiotherapy in people with Localized Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University.
Trial summary
This single-arm Phase II study will evaluate the efficacy and safety of neoadjuvant pucotenlimab, lenvatinib, and stereotactic body radiotherapy (SBRT) in adults with localized clear cell renal cell carcinoma who are candidates for partial nephrectomy but have tumors that make the operation technically difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Localized Clear Cell Renal Cell Carcinoma
- What is being tested?
- Pucotenlimab, Lenvatinib and Stereotactic Body Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 31 Dec 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
- Voluntary written informed consent.
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Preoperative biopsy confirming clear cell renal cell carcinoma or renal cell carcinoma with a predominant clear cell component.
- Willingness to undergo partial nephrectomy.
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- A localized renal tumor for which partial nephrectomy is indicated but technically difficult: a 4-7 cm hilar tumor; a 4-7 cm tumor that is at least 75% endophytic; or a tumor larger than 7 cm.
- At least one measurable lesion suitable for repeated, accurate measurement.
- Adequate organ function: absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; hemoglobin ≥90 g/L; total bilirubin ≤1.5 × upper limit of normal (ULN); ALT and AST ≤2.5 × ULN, or ≤5 × ULN for participants with liver metastases; albumin ≥28 g/L; INR and APTT ≤1.5 × ULN. No blood component transfusion or hematopoietic growth-factor support is permitted within 2 weeks before treatment.
- Willingness and ability to comply with study visits, treatment, laboratory assessments, and other study requirements.
Who cannot join
- Lymph node metastasis or metastatic renal cell carcinoma.
- Tumor encasement of the renal artery, tumor thrombus in the renal vein, or diffuse tumor growth without a clear boundary from normal renal parenchyma.
- Inability to tolerate general anesthesia according to the preoperative assessment.
- Severe cardiovascular or cerebrovascular disease, or uncontrolled hypertension or diabetes.
- Long-term immunosuppressive therapy after organ transplantation, or current use of immunosuppressive medication.
- Active infection or fever.
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- T-cell lymphoma or multiple myeloma.
- Concurrent malignancy, current treatment for another benign or malignant tumor, or a history of another malignancy within the previous 6 months.
- Use of herbal medicines with an anticancer indication or systemic immunomodulatory agents, including thymosin, interferon, or interleukin, within 14 days before the first study treatment; local use to control pleural effusion is permitted.
- Active or potentially recurrent autoimmune disease, except vitiligo, alopecia, psoriasis, or eczema not requiring systemic therapy; hypothyroidism due to autoimmune thyroiditis requiring only a stable dose of hormone replacement; or type 1 diabetes requiring only a stable dose of insulin.
- Concurrent enrollment in another interventional clinical study, except participation in its follow-up period; participation in a noninterventional observational study is permitted.
- Known psychiatric illness or a history of drug abuse, alcohol abuse, or illicit drug use.
- Pregnancy or breastfeeding.
- Any other disease, treatment, or laboratory abnormality that may confound the study results, prevent full participation, or make participation contrary to the participant's best interests.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Phase II Study of Neoadjuvant Pucotenlimab, Lenvatinib, and Stereotactic Body Radiotherapy in Patients With Localized Clear Cell Renal Cell Carcinoma and High-Risk Partial Nephrectomy
This single-arm Phase II study will evaluate the efficacy and safety of neoadjuvant pucotenlimab, lenvatinib, and stereotactic body radiotherapy (SBRT) in adults with localized clear cell renal cell carcinoma who are candidates for partial nephrectomy but have tumors that make the operation technically difficult. Approximately 24 participants will receive up to six cycles of pucotenlimab with daily lenvatinib. SBRT will be delivered to the primary renal tumor during neoadjuvant treatment. Surgery is planned after neoadjuvant treatment. The primary outcome is objective response rate.
Read the detailed description
This is a prospective, single-arm Phase II study using a Simon optimal two-stage design. The study plans to enroll 24 participants. In stage 1, eight participants will be enrolled; if no more than three have an objective response, the study will stop for futility. Otherwise, 16 additional participants will be enrolled.
Participants will receive pucotenlimab 200 mg by intravenous infusion every 3 weeks for up to six cycles and lenvatinib 12 mg orally once daily during neoadjuvant treatment. SBRT will be delivered to the primary renal tumor at a total dose of 40 Gy in five fractions after completion of the second pucotenlimab cycle and before the fourth cycle. Tumor imaging will be performed during neoadjuvant treatment. Surgery, preferably partial nephrectomy when feasible, is planned 2 to 4 weeks after the sixth pucotenlimab cycle. Efficacy, surgical outcomes, and adverse events will be evaluated.
- Being tested
- Pucotenlimab, Lenvatinib, Stereotactic Body Radiotherapy
- Keywords
- Clear cell renal cell carcinoma; Neoadjuvant therapy; Pucotenlimab; Lenvatinib; Stereotactic body radiotherapy; Partial nephrectomy
- 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.
PucotenlimabDrug
200 mg administered by intravenous infusion once every 3 weeks for up to six cycles.
LenvatinibDrug
Lenvatinib 12 mg taken orally once daily during neoadjuvant treatment; treatment is stopped at least 3 days before surgery.
Stereotactic Body RadiotherapyRadiation
SBRT to the primary renal tumor at a total dose of 40 Gy in five fractions, delivered after completion of pucotenlimab cycle 2 and before cycle 4.
| Study group | Role | What they receive |
|---|---|---|
| Pucotenlimab Plus Lenvatinib and SBRT | Experimental | Participants will receive neoadjuvant pucotenlimab 200 mg intravenously every 3 weeks for up to six cycles and lenvatinib 12 mg orally once daily. SBRT at 40 Gy in five fractions will be delivered to the primary renal tumor after cycle 2 and before cycle 4. Surgery is planned after neoadjuvant treatment, with partial nephrectomy preferred when feasible. Receives: Drug: Pucotenlimab; Drug: Lenvatinib; Radiation: Stereotactic Body Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of participants with a complete response or partial response of the primary renal tumor according to RECIST version 1.1 during neoadjuvant treatment.
Measured: From baseline through completion of neoadjuvant treatment, approximately 18 weeks.
Secondary outcomes (5)
Major Pathological Response (MPR) Rate
Percentage of participants with major pathological response in the resected primary tumor.
Measured: At surgery, approximately 20 to 22 weeks after treatment initiation.
Partial Nephrectomy Success Rate
Percentage of participants who undergo partial nephrectomy after neoadjuvant treatment.
Measured: At surgery, approximately 20 to 22 weeks after treatment initiation.
R0 Resection Rate
Percentage of surgically treated participants with microscopically negative surgical margins.
Measured: At surgery, approximately 20 to 22 weeks after treatment initiation.
Surgical Complications
Number and percentage of participants with surgical complications, including bleeding and urinary leakage.
Measured: From surgery through the 3-month postoperative visit.
Adverse Events
Number and percentage of participants with adverse events, graded according to NCI-CTCAE version 4.0.
Measured: From informed consent through 30 days after the last dose of study medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Clear Cell Renal Cell CarcinomaStudies 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
- 24 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
- NCT07922915
- Sponsor's protocol ID
- 2024-FXY-321-Urology
- Other IDs
- 2024-FXY-321-Urology
- Acronym
- PLS-NEO-RCC
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this small study collects sensitive clinical, imaging, and molecular data that could increase the risk of participant re-identification. Study results will be reported in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Phase II Study of Neoadjuvant Pucotenlimab, Lenvatinib, and Stereotactic Body Radiotherapy in Patients With Localized Clear Cell Renal Cell Carcinoma and High-Risk Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT07922915
- Acronym / sponsor ID
- PLS-NEO-RCC / 2024-FXY-321-Urology
- Keywords
- Clear cell renal cell carcinoma; Neoadjuvant therapy; Pucotenlimab; Lenvatinib; Stereotactic body radiotherapy; Partial nephrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 6 Nov 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.
This single-arm Phase II study will evaluate the efficacy and safety of neoadjuvant pucotenlimab, lenvatinib, and stereotactic body radiotherapy (SBRT) in adults with localized clear cell renal cell carcinoma who are candidates for partial nephrectomy but have tumors that make the operation technically difficult. Approximately 24 participants will receive up to six cycles of pucotenlimab with daily lenvatinib. SBRT will be delivered to the primary renal tumor during neoadjuvant treatment. Surgery is planned after neoadjuvant treatment. The primary outcome is objective response rate.
Detailed description
This is a prospective, single-arm Phase II study using a Simon optimal two-stage design. The study plans to enroll 24 participants. In stage 1, eight participants will be enrolled; if no more than three have an objective response, the study will stop for futility. Otherwise, 16 additional participants will be enrolled.
Participants will receive pucotenlimab 200 mg by intravenous infusion every 3 weeks for up to six cycles and lenvatinib 12 mg orally once daily during neoadjuvant treatment. SBRT will be delivered to the primary renal tumor at a total dose of 40 Gy in five fractions after completion of the second pucotenlimab cycle and before the fourth cycle. Tumor imaging will be performed during neoadjuvant treatment. Surgery, preferably partial nephrectomy when feasible, is planned 2 to 4 weeks after the sixth pucotenlimab cycle. Efficacy, surgical outcomes, and adverse events will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pucotenlimab Plus Lenvatinib and SBRT | Experimental | Drug: Pucotenlimab, Drug: Lenvatinib, Radiation: Stereotactic Body RadiotherapyParticipants will receive neoadjuvant pucotenlimab 200 mg intravenously every 3 weeks for up to six cycles and lenvatinib 12 mg orally once daily. SBRT at 40 Gy in five fractions will be delivered to the primary renal tumor after cycle 2 and before cycle 4. Surgery is planned after neoadjuvant treatment, with partial nephrectomy preferred when feasible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary written informed consent.
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Preoperative biopsy confirming clear cell renal cell carcinoma or renal cell carcinoma with a predominant clear cell component.
Key exclusion criteria (14 listed)
- Lymph node metastasis or metastatic renal cell carcinoma.
- Tumor encasement of the renal artery, tumor thrombus in the renal vein, or diffuse tumor growth without a clear boundary from normal renal parenchyma.
- Inability to tolerate general anesthesia according to the preoperative assessment.
- Severe cardiovascular or cerebrovascular disease, or uncontrolled hypertension or diabetes.
- Long-term immunosuppressive therapy after organ transplantation, or current use of immunosuppressive medication.
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 |
|---|---|---|
| Pucotenlimab200 mg administered by intravenous infusion once every 3 weeks for up to six cycles. | Drug | Pucotenlimab Plus Lenvatinib and SBRT |
| LenvatinibLenvatinib 12 mg taken orally once daily during neoadjuvant treatment; treatment is stopped at least 3 days before surgery. | Drug | Pucotenlimab Plus Lenvatinib and SBRT |
| Stereotactic Body RadiotherapySBRT to the primary renal tumor at a total dose of 40 Gy in five fractions, delivered after completion of pucotenlimab cycle 2 and before cycle 4. | Radiation | Pucotenlimab Plus Lenvatinib and SBRT |
Primary outcome
Objective Response Rate (ORR)
Time frame: From baseline through completion of neoadjuvant treatment, approximately 18 weeks.
Percentage of participants with a complete response or partial response of the primary renal tumor according to RECIST version 1.1 during neoadjuvant treatment.
5 secondary outcomes
Major Pathological Response (MPR) Rate
Time frame: At surgery, approximately 20 to 22 weeks after treatment initiation.
Partial Nephrectomy Success Rate
Time frame: At surgery, approximately 20 to 22 weeks after treatment initiation.
R0 Resection Rate
Time frame: At surgery, approximately 20 to 22 weeks after treatment initiation.
Surgical Complications
Time frame: From surgery through the 3-month postoperative visit.
Adverse Events
Time frame: From informed consent through 30 days after the last dose of study medication.
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 6 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this small study collects sensitive clinical, imaging, and molecular data that could increase the risk of participant re-identification. Study results will be reported in aggregate form.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pucotenlimab, Lenvatinib and Stereotactic Body Radiotherapy in people with Localized Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University.
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 10 inclusion and 14 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yulu Peng, Doc (02087342318, pengyl1@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) (time frame: From baseline through completion of neoadjuvant treatment, approximately 18 weeks.). 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 6 Nov 2026.