Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT06574412
Brief Summary:
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.
Study:
NCT06574412
Study Brief:
Protocol Section:
NCT06574412