Actively Recruiting
PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
Led by Jinling Hospital, China · Updated on 2025-09-16
30
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase 2 trial aims to test the feasibility and efficiency of PET/CT-directed treatment interruption strategy in metastatic renal cell carcinoma patients with IMDC favorable/intermediate risk who achieve complete (CMR) or partial metabolic response (PMR) after ≥12 months of first-line PD-1/PD-L1 Immune checkpoint inhibitor (ICI)+ VEGFR-tyrosine kinase inhibitor (TKI) therapy. It helps figure out whether PET/CT can safely direct treatment pause as well as explores a new individualized treatment option based on metabolic imaging for RCC patients.
CONDITIONS
Official Title
PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years or older at time of informed consent
- Locally advanced or metastatic renal cell carcinoma (AJCC Stage IV) not amenable to curative surgery or radiation
- Favorable or intermediate risk as per IMDC criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Karnofsky Performance Status (KPS) of 70% or higher
- Adequate organ and bone marrow function meeting specified laboratory criteria
- Ability to understand and comply with protocol requirements and provide informed consent
- Agreement to contraception use during study and for 5 months after last treatment if sexually active and fertile
- Negative pregnancy test for women of childbearing potential at screening
- Completion of at least 12 months of first-line PD-1/PD-L1 ICI plus VEGFR-TKI therapy without toxicity preventing continuation
- Achieved complete or partial metabolic response on PET/CT within 24 months of combination treatment
You will not qualify if you...
- Highly malignant pathology
- Prior systemic therapy for advanced RCC
- Poor risk by IMDC criteria
- ECOG performance status greater than 1
- Karnofsky Performance Status less than 70%
- Inadequate organ or bone marrow function
- Bulky or symptomatic disease or liver metastases
- Active brain metastases or leptomeningeal disease unless treated and stable for at least 3 months
- Concurrent or prior invasive malignancies that may confound assessment, except certain treated cancers over 3 years ago
- Uncontrolled hypertension (>150/100 mmHg despite therapy)
- Uncontrolled significant comorbidities within 6 months including cardiovascular disorders, gastrointestinal risks, major bleeding history, severe infections, autoimmune diseases, or active HIV, HBV, or HCV
- Major surgery within 4 weeks with unhealed wounds or planned surgery during study
- Use of drugs affecting investigational product activity or pharmacokinetics
- Hypersensitivity to study drugs
- Chronic or concurrent immunosuppressive therapy except inhaled/topical steroids
- Medical, psychiatric, or social conditions affecting protocol compliance
- Pregnancy, lactation, or refusal of contraception during and for 5 months after study
- Inability to undergo PET/CT or oral drug administration
- Failure to complete 12 months of first-line therapy due to toxicity or other reasons
- Failure to achieve complete or partial metabolic response on PET/CT within 24 months
- Disease progression, new metastatic lesions, or inadequate response on PET/CT
- Poor patient compliance or loss to follow-up
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
L
Le Qu, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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