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Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

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

NCT06138496•Sun Yat-sen University

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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:
+5 more criteria

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
+9 more criteria

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Other (Non U.s.), China

Key Dates

Start Date

September 1, 2023

Primary Completion Date

December 9, 2024

Completion Date

December 31, 2025

Last Updated

January 5, 2026

Enrollment

ACTUAL participants

Conditions

CadonilimabClear Cell Renal Cell CarcinomaNeoadjuvant Therapy

Interventions

Cadonilimab Combined With Lenvatinib

DRUG

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

Inclusion Criteria

Exclusion Criteria

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

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