NCT07922915Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
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
Source: ClinicalTrials.gov · Last updated 6 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 2 Nov 2026
- Start date
- 10 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Kidney cancer
- NCT number
- NCT07922915
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 24
- From 10 Nov 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with kidney cancer (clear cell type) that has not spread and who will have part of the kidney removed. The tumor must make that operation technically difficult.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Kidney cancer of the clear cell type, confirmed by biopsy, in the kidney only. The tumor makes partial nephrectomy 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.
- Earlier treatment
- No blood transfusion or blood growth-factor support within 2 weeks before treatment. No herbal anticancer medicines or immune-modulating drugs (thymosin, interferon, interleukin) within 14 days before the first study treatment.
Main reasons for not taking part
- Cancer in the lymph nodes or spread to other organs
- Tumor around the renal artery, tumor clot in the renal vein, or tumor with no clear edge from normal kidney tissue
- Severe heart or brain blood vessel disease, or uncontrolled high blood pressure or diabetes
- Active or likely returning autoimmune disease, with a few exceptions listed in the record
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Long-term immunosuppressive therapy after organ transplantation, or current use of immunosuppressive medication.
- 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.
- Concurrent enrollment in another interventional clinical study, except participation in its follow-up period; participation in a noninterventional observational study is permitted.
Other illness
- Severe cardiovascular or cerebrovascular disease, or uncontrolled hypertension or diabetes.
- Active infection or fever.
- Concurrent malignancy, current treatment for another benign or malignant tumor, or a history of another malignancy within the previous 6 months.
- 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.
- Known psychiatric illness or a history of drug abuse, alcohol abuse, or illicit drug use.
Lab values
- 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.
Other
- 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.
- T-cell lymphoma or multiple myeloma.
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.