CD70-Targeted Immuno-PET/CT-Directed Free of Therapy Used for mccRCC Patients With IMDC Favorable or Intermediate Risk
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China
About this trial
The purpose of this study is to evaluate the safety and feasibility of a treatment holiday strategy directed by CD70-targeted immuno-PET/CT in patients with metastatic clear cell renal cell carcinoma (mccRCC). Specifically, the study aims to assess whether patients who achieve both anatomical disease control and metabolic response after 12 months of first-line PD-1/PD-L1 ICI + VEGFR-TKI combination therapy can safely pause their treatment, improve quality of life without compromising therapeutic efficacy.
Eligibility criteria
Qualifiers
Male or female subjects aged ≥ 18 years
Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer [AJCC] Stage IV)
Histologically or cytologically confirmed advanced RCC with predominantly clear-cell subtype
Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
Disqualifiers
Prior systemic therapy for advanced RCC
Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
Karnofsky Performance Status (KPS) <70%
Inadequate organ and bone marrow function
Trial design
Treatments tested in this trial
- PD-1/PD-L1 ICI + VEGFR-TKI
- Treatment pause
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov