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Clear Cell Renal Cell CarcinomaPhase 2NCT06138496

Cadonilimab Combination With Lenvatinib as Neoadjuvant Therapy for ccRCC

A Phase 2 study testing Cadonilimab Combined With Lenvatinib in people with Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
Cadonilimab Combined With Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
1 Sep 2023to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN
  • Serum albumin (ALB) ≥28 g/L
  • Coagulation:
  • International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory assessments, and all other study requirements.

Who cannot join

  • 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
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  • 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)
  • Active or potentially relapsing autoimmune disease; the following conditions are exempt: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism secondary to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type 1 diabetes mellitus requiring only stable-dose insulin replacement therapy
  • Concurrent enrollment in another clinical study, unless it is an observational/non-interventional study or the follow-up phase of an interventional study
  • Known history of psychiatric illness, substance abuse, alcohol dependence, or illicit drug use
  • Pregnant or breastfeeding women
  • Any concurrent disease, prior treatment, or laboratory abnormality that may confound study results, interfere with the subject's full study participation, or indicate that participation may not be in the subject's best interest

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

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

Other trials in China

About this study

Official title: A Single-Arm Phase II Clinical Study Evaluating the Efficacy and Safety of Cadonilimab Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cell Carcinoma Patients With Partial Nephrectomy Indications But High Surgical Risk

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)

Being tested
Cadonilimab Combined With Lenvatinib
Keywords
Cadonilimab, Neoadjuvant therapy, Clear Cell Renal Cell Carcinoma
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cadonilimab Combined With LenvatinibDrug

    • 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.
Study groups in NCT06138496
Study groupRoleWhat they receive
Cadonilimab combined with Lenvatinib as neoadjuvant therapyExperimentalNot described
Receives: Drug: Cadonilimab Combined With Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

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

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

Secondary outcomes (5)

  1. Major Pathological Response rate (MPR)

    The proportion of patients with residual viable tumor cells in tumor specimens and lymph nodes resected after neoadjuvant therapy, which are ≤10%.

    Measured: The evaluation was conducted 5 days after surgery.

  2. Nephron-sparing surgery (NSS) success rate

    The success rate of all enrolled patients undergoing partial nephrectomy.

    Measured: Evaluation at the end of surgery.

  3. R0 resection rate

    R0 resection rate refers to the percentage of patients in whom a tumor is surgically removed with no microscopic residual disease. Specifically, it means that after pathological examination of the resected specimen, the tumor margins are negative (no cancer cells are found at the cut edge).

    Measured: The evaluation was conducted 5 days after surgery.

  4. Surgical complication rate

    Surgical complication rate is the proportion of patients who experience any unintended, adverse event (such as infection, bleeding, organ injury, or anastomotic leak) following a surgical procedure

    Measured: From the end of surgery to three months after surgery

  5. Drug safety profile

    Incidence and severity of adverse events during the use of Cadonilimab and Lenvatinib.

    Measured: During the treatment of combination of Cadonilimab and Lenvatinib.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2023
  2. Study start1 Sep 2023
  3. Primary completion9 Dec 2024
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06138496
Sponsor's protocol ID
2023-FXY-117
Status last verified
Apr 2026
First submitted
13 Nov 2023
Last updated
21 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab Combined With Lenvatinib in people with Clear Cell Renal Cell Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06138496.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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