Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06138496
• Other study ID #: 2023-FXY-117
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Sun Yat-sen University
• Contact: Zhiling Zhang, M.D
• Phone: +862087342318
• Email: zhangzhl[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 43
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Voluntary written informed consent (ICF).

2. Age =18 years old at the time of enrollment, male or female.

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

4. Expected survival =3 months.

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

6. ECOG score 0 or 1

7. The patient has the intention of kidney preservation operation

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

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

10. 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) :

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

2. Platelet count (PLT) = 100×109/L (100,000/mm3);

3. 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.

Exclusion Criteria:

• Lymph node metastasis
• Tumor surrounds renal artery
• Cancer thrombus in renal vein
• The tumor is diffuse and has no clear boundary with normal renal parenchyma
• Poor general status, anaesthetic assessment can not tolerate general anesthesia surgery
• Severe cardiovascular and cerebrovascular diseases, uncontrolled hypertension and diabetes
• Patients on long-term immunosuppressant use after organ transplantation
• Patients who are taking immunosuppressive drugs
• Patients with a definite infection or fever
• Patients with T-cell lymphoma and myeloma
• Patients who are combined with other malignant tumors, or are in the course of treatment for other benign and malignant tumors, or have a history of other malignant tumors within the past six months
• Metastatic kidney cancer.
• Received Chinese herbal medicines with anti-tumor indications or immunomodulatory effects within 14 days prior to the first use of the study drug
• Systematic therapy (including thymosin, interferon, interleukin, except for topical use to control pleural effusion).
• Have an autoimmune disease that is active or likely to recur, except for vitiligo, alopecia, psoriasis, or eczema that does not require systemic treatment; Hypothyroidism due to autoimmune thyroiditis requires only stable dose hormone replacement therapy; Only a steady dose of insulin replacement is required for type 1 diabetes. Enrolling in another clinical study at the same time, unless it is an observational, non-interventional clinical study or follow-up period of an interventional study.
• Known history of mental illness, substance abuse, alcohol or drug use.
• Pregnant or breastfeeding women.
• The presence of any past or current medical condition, treatment, or laboratory test abnormality that may confuse the study results, interfere with the subject's full participation in the study, or that participation in the study may not be in the subject's best interest.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Neoadjuvant Therapy

Intervention

Drug:
• Cadonilimab Combined With Lenvatinib
3.7.1 Lenvatinib Treatment Lenvatinib (8mg [body weight < 60 kg] or 12 mg [body weight = 60 kg]) orally once daily, with or without food. 3.7.2 Intravenous Infusion of Cardonilli (Injection) Infuse Cardonilli at a dose of 6mg/kg intravenously every two weeks, constituting one treatment cycle, a total of 6 cycles.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Objective Response Rate (ORR) based on RECIST 1.1 criteria.	Evaluation at the end of Cycle 6 (each cycle is 14 days) of Cadonilimab treatment