New drug combo helps High-Risk kidney cancer patients avoid full kidney removal
NCT ID NCT06138496
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of two drugs (cadonilimab and lenvatinib) given before surgery to 39 people with kidney cancer that was difficult to operate on while saving the kidney. The goal was to shrink the tumor enough to allow a partial, kidney-sparing surgery instead of removing the whole kidney. The approach aims to make surgery safer and preserve kidney function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntary provision of written informed consent prior to any study-related procedures. 2. Age ≥18 years at the time of enrollment; no restriction on sex. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 4. Estimated survival ≥3 months. 5. Pathological confirmation of clear cell RCC or predominantly clear cell renal cell carcinoma by preoperative needle biopsy. 6. Patient willingness to undergo nephron-sparing surgery. 7. Presence of indications for nephron-sparing surgery but with high surgical complexity: 1) tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75%; or 2) tumors \>7 cm. 8. At least one measurable lesion per RECIST v1.1 criteria, suitable for repeated accurate measurement. 9. Adequate organ function, with laboratory results during the screening period meeting all of the following criteria: Hematology (no blood component or colony-stimulating factor support permitted within 2 weeks prior to treatment initiation): * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1,500/mm³) * Platelet count (PLT) ≥100 × 10⁹/L (≥100,000/mm³) * Hemoglobin (Hb) ≥90 g/L Hepatic function: * Serum total bilirubin (TBIL) ≤1.5 × ULN * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN * Serum albumin (ALB) ≥28 g/L Coagulation: \- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN 10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory assessments, and all other study requirements. Exclusion Criteria: Patients meeting any of the following criteria will be ineligible for participation: 1. Lymph node metastasis 2. Tumor encasing the renal artery 3. Tumor thrombus within the renal vein 4. Diffuse tumor growth without a clear boundary with normal renal parenchyma 5. Poor general condition precluding tolerance of general anesthesia based on anesthesiological assessment 6. Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, or uncontrolled diabetes mellitus 7. Long-term use of immunosuppressive agents following organ transplantation 8. Current use of immunosuppressive medications 9. Active or clinically apparent infection or fever 10. T-cell lymphoma or multiple myeloma 11. Concurrent other malignancies, currently undergoing treatment for other benign or malignant tumors, or a history of other malignancies within the preceding 6 months 12. Metastatic renal cell carcinoma 13. Receipt of traditional Chinese herbal medicines with antitumor indications or immunomodulatory agents within 14 days prior to the first dose of study drug 14. Ongoing systemic therapy (including thymosin, interferon, or interleukins; local use for control of pleural effusion is permitted) 15. Active or potentially relapsing autoimmune disease; the following conditions are exempt: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism secondary to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type 1 diabetes mellitus requiring only stable-dose insulin replacement therapy 16. Concurrent enrollment in another clinical study, unless it is an observational/non-interventional study or the follow-up phase of an interventional study 17. Known history of psychiatric illness, substance abuse, alcohol dependence, or illicit drug use 18. Pregnant or breastfeeding women 19. Any concurrent disease, prior treatment, or laboratory abnormality that may confound study results, interfere with the subject's full study participation, or indicate that participation may not be in the subject's best interest
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Other (Non U.s.), 0755, China
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