Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

NCT06138496 | Completed Phase 2 DMC

• 1 other identifier: 2023-FXY-117
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Through the neoadjuvant treatment with a combination of Cadonilimab 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 (tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75% or tumors \>7 cm)

Conditions

Clear Cell Renal Cell Carcinoma

Keywords

Cadonilimab; Neoadjuvant therapy; Clear Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate (ORR) based on RECIST 1.1 criteria.

  Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment

Secondary Outcomes (5)

• Major Pathological Response rate (MPR)

  The evaluation was conducted 5 days after surgery.

• Nephron-sparing surgery (NSS) success rate

  Evaluation at the end of surgery.

• R0 resection rate

  The evaluation was conducted 5 days after surgery.

• Surgical complication rate

  From the end of surgery to three months after surgery

• Drug safety profile

  During the treatment of combination of Cadonilimab and Lenvatinib.

Study Arms (1)

Cadonilimab combined with Lenvatinib as neoadjuvant therapy

EXPERIMENTAL

Drug: Cadonilimab Combined With Lenvatinib

Interventions

Cadonilimab Combined With Lenvatinib DRUG

* 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 3 or 6 cycles.

Cadonilimab combined with Lenvatinib as neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary provision of written informed consent prior to any study-related procedures.
• Age ≥18 years at the time of enrollment; no restriction on sex.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Estimated survival ≥3 months.
• Pathological confirmation of clear cell RCC or predominantly clear cell renal cell carcinoma by preoperative needle biopsy.
• Patient willingness to undergo nephron-sparing surgery.
• Presence of indications for nephron-sparing surgery but with high surgical complexity: 1) tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75%; or 2) tumors \>7 cm.
• At least one measurable lesion per RECIST v1.1 criteria, suitable for repeated accurate measurement.
• Adequate organ function, with laboratory results during the screening period meeting all of the following criteria:
• Hematology (no blood component or colony-stimulating factor support permitted within 2 weeks prior to treatment initiation):
• Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1,500/mm³)
• Platelet count (PLT) ≥100 × 10⁹/L (≥100,000/mm³)
• Hemoglobin (Hb) ≥90 g/L
• Hepatic function:
• Serum total bilirubin (TBIL) ≤1.5 × ULN

You may not qualify if:

• Patients meeting any of the following criteria will be ineligible for participation:
• Lymph node metastasis
• Tumor encasing the renal artery
• Tumor thrombus within the renal vein
• Diffuse tumor growth without a clear boundary with normal renal parenchyma
• Poor general condition precluding tolerance of general anesthesia based on anesthesiological assessment
• Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, or uncontrolled diabetes mellitus
• Long-term use of immunosuppressive agents following organ transplantation
• Current use of immunosuppressive medications
• Active or clinically apparent infection or fever
• T-cell lymphoma or multiple myeloma
• Concurrent other malignancies, currently undergoing treatment for other benign or malignant tumors, or a history of other malignancies within the preceding 6 months
• Metastatic renal cell carcinoma
• Receipt of traditional Chinese herbal medicines with antitumor indications or immunomodulatory agents within 14 days prior to the first dose of study drug
• Ongoing systemic therapy (including thymosin, interferon, or interleukins; local use for control of pleural effusion is permitted)

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Other (Non U.s.), 0755, China

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: September 1, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 31, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)