Status:
RECRUITING
PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk
Lead Sponsor:
Jinling Hospital, China
Conditions:
Renal Cell Carcinoma (RCC)
Metastatic Renal Cell Carcinoma (mRCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Current first-line therapy for advanced renal cell carcinoma (RCC) combines tyrosine kinase inhibitors (TKIs) with immune checkpoint inhibitors (ICIs). Although effective, continuous treatment often r...
Eligibility Criteria
Inclusion
- Pre-screening
- Male or female subjects aged ≥ 18 years at time of signing informed consent
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC (American Joint Committee on Cancer \[AJCC\] Stage IV)
- Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- Eastern Cooperative Oncology Group performance status 0 or 1
- Karnofsky Performance Status (KPS) grade ≥ 70%
- Adequate organ and bone marrow function meeting all laboratory criteria:
- Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
- Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome)
- Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula.
- Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
- Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment
- Negative pregnancy status at screening for women of childbearing potential
- Pre-screening
Exclusion
- Highly malignant pathology
- Prior systemic therapy for advanced RCC
- Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- ECOG performance status \>1
- Karnofsky Performance Status (KPS) \<70%
- Inadequate organ and bone marrow function
- Bulky or symptomatic disease or hepatic metastases
- Active brain metastases or leptomeningeal disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before the start of treatment.
- Concurrent or prior invasive malignancies that could confound efficacy assessment, except adequately treated non-melanoma skin cancer, superficial bladder cancer or carcinoma in situ of the cervix/breast with curative therapy \>3 years ago.
- Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy)
- Uncontrolled comorbidities within 6 months including but not limited to: clinically significant cardiovascular disorders, gastrointestinal disorders with high risk of perforation or fistula formation, significant hematuria, hematemesis, hemoptysis, or major bleeding history, severe infections, severe autoimmune diseases (e.g., systemic lupus erythematosus, immune pneumonitis), active HIV, HBV, or HCV infections.
- Major surgery within 4 weeks with unhealed wounds or planned surgery during study
- Concomitant use of drugs or substances affecting activity or pharmacokinetics of investigational products
- Hypersensitivity to any component of study drugs
- Chronic or concurrent immunosuppressive therapy, except Inhaled/topical steroids
- Medical/psychiatric/social conditions compromising protocol compliance
- Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment
- Inability to undergo PET/CT or oral drug administration
- Main-screening Inclusion Criteria:
- Patient must receive≥12 months of first line treatment with the combination of PD-1/PD-L1 ICI and VEGFR-TKI, and have not experienced a toxicity that prevents them from continuing on therapy.
- Patients must achieve complete metabolic response (CMR) or partial metabolic response (PMR) on PET/CT within 24 months of the combination treatment with PD-1/PD-L1 ICI and VEGFR-TKI.
- Favorable or intermediate risk as per International Metastatic RCC Database Consortium (IMDC) criteria
- Eastern Cooperative Oncology Group performance status 0 or 1
- Karnofsky Performance Status (KPS) grade ≥ 70%
- Adequate organ and bone marrow function meeting all laboratory criteria:
- Ⅰ. Absolute neutrophil count (ANC) ≥ 1.5 × 10³/μL (≥ 1.5 GI/L); Platelet count ≥ 100 × 10³/μL (≥ 100 GI/L); Hemoglobin ≥ 9 g/dL (≥ 90 g/L)
- Ⅱ. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 × upper limit of normal. Total bilirubin ≤ 1.5 × the upper limit of normal (≤ 3 mg/dL \[≤ 51.3 μmol/L\] if Gilbert's syndrome)
- Ⅲ. Serum creatinine ≤ 2.0 × upper limit of normal or calculated creatinine clearance ≥ 30 mL/min using the Cockroft-Gault formula.
- Capacity to comprehend and comply with protocol requirements, with documented informed consent signed
- Contraception agreement for sexually active fertile participants and partners to use of medically accepted methods during study and continue for 5 months after last treatment
- Negative pregnancy status at screening for women of childbearing potential
- Main-screening
Key Trial Info
Start Date :
January 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07175480
Start Date
January 24 2025
End Date
August 1 2030
Last Update
September 16 2025
Active Locations (1)
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1
Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China
Nanjing, Jiangsu, China