A Multicenter Real-World Study on TKI Therapy After Progression on First-Line TKI/IO Therapy or T… (NCT07324876) | Clinical Trial Compass
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A Multicenter Real-World Study on TKI Therapy After Progression on First-Line TKI/IO Therapy or TKI/IO Therapy After Progression on First-Line TKI in Chinese Patients With Metastatic Renal Cell Carcinoma (mRCC)
China860 participantsStarted 2025-12-31
Plain-language summary
TKI monotherapy or TKI/IO combination therapy is the standard first-line treatment for low- and intermediate-risk advanced renal cell carcinoma (RCC). In clinical practice, after the failure of first-line therapy, sequential treatment is often selected based on the initial regimen, with options including TKI/IO therapy or TKI therapy. In the real-world setting of low- and intermediate-risk advanced RCC in China, which sequential treatment strategy-TKI/IO-TKI or TKI-TKI/IO-provides greater survival benefits for patients? This study aims to compare the efficacy, safety, and cost-effectiveness of TKI/IO-TKI sequential therapy versus TKI-TKI/IO sequential therapy in real-world low- and intermediate-risk mRCC patients. The objective is to accurately identify the optimal patient subgroups for each treatment strategy, optimize treatment plans, improve patient quality of life, reduce healthcare costs, provide guidance and reference for the clinical management of low- and intermediate-risk mRCC patients, and contribute to the refinement and updating of related Chinese treatment guidelines.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. Subjects with histologically confirmed unresectable metastatic renal cell carcinoma (mRCC) will be included in the study. Previous nephrectomy or metastasectomy is allowed, but no prior systemic anticancer therapy targeting RCC is permitted.
✓. Classified as low- or intermediate-risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria.
✓. Male or female subjects aged 18 years or older at the time of signing the informed consent form.
✓. Defined as Chinese ethnicity, with both biological parents and all four biological grandparents being of Chinese descent.
✓. Patients who progressed or were intolerant to first-line TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.) and subsequently received TKI/IO therapy (including axitinib/ lenvatinib/ cabozantinib combined with toripalimab/ tislelizumab/ pembrolizumab/ sintilimab/ nivolumab, etc.).
✓. Patients who progressed or were intolerant to first-line TKI/IO therapy (including axitinib/ lenvatinib/ cabozantinib combined with toripalimab/ tislelizumab/ pembrolizumab/ sintilimab/ nivolumab, etc.) and subsequently received TKI therapy (including sunitinib, pazopanib, cabozantinib, sorafenib, axitinib, lenvatinib, etc.).
✓. Karnofsky Performance Status (KPS) ≥ 70% within 10 days prior to the first dose of treatment.
What they're measuring
1
PFS2
Timeframe: 1year
Trial details
NCT IDNCT07324876
SponsorTianjin Medical University Cancer Institute and Hospital
✓. Adequate organ function as evidenced by laboratory values: ANC ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 10.0 g/dL or ≥ 6.2 mmol/L; CrCl ≥ 30 mL/min; AST and ALT ≤ 2.5 × ULN; total bilirubin ≤ 1.5 × ULN; and INR or PT ≤ 1.5 × ULN.
Exclusion criteria
✕. Requiring intermittent oxygen supplementation at rest, or long-term oxygen therapy.
✕. Clinically significant cardiovascular disease within 6 months prior to the first dose of study intervention.
✕. Severe active, non-healing wound, ulcer, or fracture.
✕. Use of colony-stimulating factors (e.g., G-CSF, GM-CSF), recombinant erythropoietin (EPO), or blood transfusion within 28 days prior to the first dose of study intervention.
✕. Inability to swallow oral medications or a history of, or current evidence of, gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver function, or other conditions that, in the investigator's opinion, may significantly alter the absorption or metabolism of oral study interventions.
✕. Severe hypersensitivity reactions to TKI drugs, IO drugs, and/or any excipients.
✕. Diagnosis of immunodeficiency or use of long-term systemic corticosteroids (daily dose exceeding 10 mg prednisone or equivalent) or any form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
✕. Diagnosis of another malignancy (excluding RCC treated by nephrectomy and/or metastasectomy) that is currently progressing or required active treatment in the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding bladder carcinoma in situ) who have undergone potentially curative treatment are eligible.