Neoadjuvant of Axitinib Plus PD-1 to Improve Disease Free Survival of Patients With Renal Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorZHOU FANGJIAN
About this trial
The study included 298 RCC patients who were at high risk for recurrence after nephrectomy (T2G3-4 or T3-4 or N1). They were randomly divided to receive axitinib plus PD-1 + surgery or surgery alone at a ratio of 1:1, so as to determine the efficacy of the neoadjuvant combination of axitinib plus PD-1.
Eligibility criteria
Qualifiers
Voluntarily agree to participate in this study and sign the informed consent form;
Males or females between 18 years old and 80 years old;
Diagnosed as clear cell carcinoma or renal cell carcinoma predominantly composed of clear cell carcinoma through histopathological examination
CT or MRI clinical staging is T2G4 or T2 with sarcomatoid differentiation, T3-4, N1;
Disqualifiers
With distant metastasis
Severe liver and renal dysfunction, combined with other serious diseases;
Serious cardiovascular disease, including any of the following: myocardial infarction or arteritis or venous thrombosis (such as pulmonary embolism) in the past 1 year;
Severe/unstable angina pectoris; uncontrolled hypertension;
Trial design
Treatments tested in this trial
- Axitinib plus Toripalimab
- nephrectomy
Treatment groups
298 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov