Combination of Cadonilimab and Lenvatinib for Kidney Cancer Treatment

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

This study is testing if a combination of two drugs, Cadonilimab and Lenvatinib, can help people with localized kidney cancer have better surgery outcomes and keep more of their kidney.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Lenvatinib
• Locations: 1 site (Guangzhou, Other (Non U.s.))
• Trial ID: NCT06138496 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of a combination of Cadonilimab and Lenvatinib as neoadjuvant therapy for patients with localized clear cell renal cell carcinoma (ccRCC) who are candidates for nephron-sparing surgery. The goal is to facilitate successful partial nephrectomy in patients facing challenges in kidney preservation due to tumor characteristics. Eligible participants will undergo treatment prior to surgery, with the aim of improving surgical outcomes and preserving kidney function.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed clear cell renal cell carcinoma and indications for difficult kidney-preserving surgery.

Not a fit: Patients with non-clear cell renal cell carcinoma or those not facing challenges in kidney preservation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance surgical options and outcomes for patients with challenging kidney tumors.

How similar studies have performed: While there is ongoing research in neoadjuvant therapies for renal cell carcinoma, the specific combination of Cadonilimab and Lenvatinib in this context is novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Other (Non U.s.)

• Sun Yat-sen University Cancer Center — Guangzhou, Other (Non U.s.), China (Recruiting)

Study contacts

• Study coordinator: Zhiling Zhang, M.D

Conditions Cadonilimab; Clear Cell Renal Cell Carcinoma; Neoadjuvant Therapy; Neoadjuvant therapy