Phase II Single-arm Clinical Study of the Efficacy and Safety of Cadonilimab in Combination With Lenvatinib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Through the neoadjuvant treatment with a combination of Cardonilli and Lenvatinib, 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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Voluntary written informed consent (ICF).

• Age ≥18 years old at the time of enrollment, male or female.

• The Eastern United States Cancer Collaboration (ECOG) Physical Fitness score is 0 or 1.

• Expected survival ≥3 months.

• Preoperative biopsy pathologically confirmed clear cell carcinoma of kidney or renal cell carcinoma dominated by clear cell carcinoma

• ECOG score 0 or 1

• The patient has the intention of kidney preservation operation

• There are indications for kidney-preserving surgery, but the operation is difficult (T1b endogenous ≥75% or T2).

• Have at least one measurable lesion (according to mRECIST v1.1) suitable for repeated accurate measurement.

⁃ Good organ function, laboratory test results during the screening period meet the following criteria:

‣ (1) Hematology (no use of blood components and cell growth factors to support therapy within 2 weeks before starting treatment) :

• neutrophil absolute value (ANC) ≥ 1.5×109/L (1,500/mm3);

• Platelet count (PLT) ≥ 100×109/L (100,000/mm3);

• Hemoglobin (HB) ≥ 90 g/L; (2) Liver:

‣ a. Serum total bilirubin (TBIL) ≤ 1.5×ULN; b. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5×ULN; For subjects with liver metastasis, AST and ALT ≤ 5×ULN c. Serum albumin (ALB) ≥28g/L (3) Coagulation function: International Standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN 11. Subject is willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Zhiling Zhang, M.D
zhangzhl@sysucc.org.cn
+862087342318
Backup
Yulu Peng, M.D
pengyl1@sysucc.org.cn
+862087342318
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 43
Treatments
Experimental: Cadonilimab combined with Lenvatinib as neoadjuvant therapy
Lenvatinib Treatment Lenvatinib (8mg \[body weight \< 60 kg\] or 12 mg \[body weight ≥ 60 kg\]) orally once daily, with or without food.~Intravenous Infusion of Cadonilimab(Injection) Infuse Cadonilimab at a dose of 6mg/kg intravenously every two weeks, constituting one treatment cycle, a total of 6 cycles.~Radical nephrectomy; Utilization of other targeted therapies; Combination targeted therapy with immunotherapy. If not, continue medication for six cycles before surgery.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov

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