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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
PD-1/PD-L1 ICI + VEGFR-TKI
DrugAll participants will receive first-line PD-1/PD-L1 inhibitor + VEGFR-TKI combination therapy for 12 months (±1 month).
Treatment pause
Other interventionPatients who achieve the predefined criteria after 12 months of treatment will discontinue both drugs and enter a closely monitored treatment holiday. Upon radiographic or clinical progression, the previous systemic therapy will be reintroduced according to the protocol and investigator's discretion.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Treatment Holiday StrategyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Treatment-free survival (TFS) rate
Defined as the proportion of patients who are alive without having restarted the original therapy at 12 months following discontinuation of the combination therapy.
Time frame
12 months after treatment discontinuationSecondary outcomes
1
Overall survival (OS)
Time from enrollment to date of death due to any cause.
Time frame
From treatment initiation until 3 years of follow-up2
Progression free survival (PFS)
Time from enrollment to first documented disease progression or death, whichever occurs first.
Time frame
From treatment initiation until 3 years of follow-up3
Overall safety profile
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 criteria.
Time frame
From treatment initiation until 3 years of follow-up4
Patient-reported outcome (PRO) - Health-related quality of life measured by NCCN FKSI-19
Measured by the NCCN functional assessment of cancer therapy-kidney symptom index (FKSI-19), a 19-item scale assessing treatment-related symptoms and side effects for kidney cancer patients.
Time frame
From treatment initiation until 2 years of follow-upSponsors and contacts
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Source ClinicalTrials.gov