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NCT06574412

Cardenilimab Combined With Lenvatinib in Patients With Perioperative Resectable Clear Cell Renal Cell Carcinoma.

Not yet recruiting Phase 2 Last updated 28 August 2024
What this trial tests

Phase 2 trial testing cardonilizumab combined with renvastinib in Resectable Clear Cell Carcinoma of the Kidney in 30 participants. Not yet recruiting.

Timeline
1 September 2024
Primary endpoint
31 August 2027
1 September 2027

Quick facts

Lead sponsorThe First Hospital of Jilin University
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date1 September 2024
Primary completion31 August 2027
Estimated completion1 September 2027

Drugs / interventions tested

Conditions studied

Sponsor

The First Hospital of Jilin University

Who can join

Adults 18 to 75, any sex, with Resectable Clear Cell Carcinoma of the Kidney. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-arm, single-center, phase II clinical study. The main purpose is to evaluate the perioperative efficacy and safety of cardenilimab combined with lenvatinib in patients with resectable clear cell renal cell carcinoma. This study included a screening period, a treatment period, and a follow-up period. After completing the examination and assessment during the screening period, qualified subjects will enter the study treatment period after signing the informed consent form. Subjects should receive induction therapy and maintenance therapy in accordance with the protocol until there is disease progression on imaging as judged by the investigator based on RECIST 1.1 standards, intolerable toxicity, or the subject voluntarily requests to terminate study treatment or withdraws information. Agree, or the researcher determines that treatment needs to be terminated. (1) Primary research endpoint: Objective response rate (ORR) of primary tumor according to RECIST 1.1 criteria (2) Secondary research endpoint: 1. According to RECIST 1.1, as assessed by the investigator: (1) Progression-free survival (Progress Free Survival, PFS); (2) Overall survival (OS); 2. Type, incidence and severity of adverse events (AE) and serious adverse events (SAE) assessed in accordance with NCI-CTCAE 5.0 . 3. Pathological response rate (MPR), R0 resection rate 4. Based on Quality of Life QoL score.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Role of Systemic Therapy in Localized Renal Cell Carcinoma: Where Do We Stand and Where Are We Heading?
    Raghavan D, Gibatova V, Vojjala N, Moka N, et al · · 2025 · cited 2× · PMID 40427152 · DOI 10.3390/cancers17101656

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