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Efficacy and safety of neoadjuvant therapy with pazopanib plus PD-1 antibodies in renal cell carcinoma that having indication of partial nephrectomy but in high surgical risk: a single arm and phase II clinical trial

Efficacy and safety of neoadjuvant therapy with pazopanib plus PD-1 antibodies in renal cell carcinoma that having indication of partial nephrectomy but in high surgical risk: a single arm and phase II clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026199
Enrollment
Unknown
Registered
2019-09-26
Start date
2023-05-12
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

renal cancer

Interventions

treatment group:Neoadjuvant therapy with pazopanib plus PD-1 antibodies

Sponsors

Sun Yat-Sen University Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The preoperative biopsy pathology confirmed that the tumor is pure or mainly renal clear cell carcinoma. 2. The ECOG score is 0 or 1. 3. Clinical staging is T1, T2 or T3a. 4. Meet one item of the following three: a. Tumor(s) in solitary kidney, and the R.E.N.A.L score is equal or greater than 7. b. Bilateral renal tumors, and the R.E.N.A.L score of more complex side is equal or greater than 7 while the postoperative GFR of the less complex side is estimated less than 45 mL/min/1.73m2. c. Unilateral renal tumorand the R.E.N.A.L score is equal or greater than 7 and the contralateral renal GFR is less than 45 mL/min/1.73m2 in the meantime. 5. If the R.E.N.A.L score is7-9, it still needs to meet that: the maximum diameter of the tumor should be greater than 4cm and the tumor should be close to the renal artery/veins or their primary branches, or close to the collecting system (the distance should be less than 4mm).

Exclusion criteria

Exclusion criteria: 1. Lymph node metastasis. 2. The tumor wraps around the renal artery. 3. Renal vein tumor thrombus. 4. The tumor grows diffusely and has no obvious boundary with normal renal parenchyma. 5. The tumor invades more than 50% volume of homolateral kidney. 6. The patient has poor general condition and is assessed that could not go through the surgery under general anesthesia. 7. The patient has serious cardiovascular and cerebrovascular diseases, hypertension or diabetes unable to be controlled. 8. The patient has taken immunosuppressive drugs for a long time after organ transplantation operation. 9. The patient is taking immunosuppressive drugs at the moment. 10. The patient has a certain infection or fever. 11. The patient is diagnosed with T cell lymphoma or myeloma. 12. The patient has autoimmune disease. 13. The patient is tested with positive HIVor other immunodeficiency diseases. 14. Patients with other malignant tumors, or who are undergoing treatment for other benign or malignant tumors, or who have a history of other malignant tumors within the previous six months.

Design outcomes

Primary

MeasureTime frame
tumor volume;

Secondary

MeasureTime frame
R.E.N.A.L score;objective response rate;

Countries

China

Contacts

Public ContactZhang Zhiling

Department of Urology, Sun Yat-Sen University Cancer Center

zhangzhl@sysucc.org.cn+86 139 2952 7746

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026