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:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT06577961
Brief Summary:
Evaluate the efficacy and safety of vorolanib combined with cadonilimab in the treatment of untreated advanced RCC patients.
Detailed Description:
This study is a multicenter, prospective, phase I/II single-arm trial, aiming to enroll 37 untreated patients with advanced or metastatic ccRCC to receive vorolanib combined with cadonilimab treatment, and to perform CTC/ctDNA testing on subjects.
In the phase I dose exploration phase, a 3+3 dose escalation method is used to explore the safety of vorolanib at the standard dose combined with cadonilimab within one treatment cycle, and to determine the dose.
In the phase II trial phase, the dosage of vorolanib is determined by the optimal tolerated dose found in the phase I trial, while cadonilimab is combined for treatment.
Patients need to be evaluated for efficacy and safety after every 2 treatment cycles (within ±3 days at the end of each cycle), and continue treatment until disease progression, intolerable toxicity, or completion of the prescribed treatment cycle.
Study:
NCT06577961
Study Brief:
Protocol Section:
NCT06577961