PET/CT-Directed Free of Therapy for Metastatic RCC Patients With IMDC Favorable or Intermediate Risk

Exclusion Criteria

• •1. Highly malignant pathology
• •2. Prior systemic therapy for advanced RCC
• •3. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• •4. ECOG performance status \>1
• •5. Karnofsky Performance Status (KPS) \<70%
• •6. Inadequate organ and bone marrow function
• •7. Bulky or symptomatic disease or hepatic metastases
• •8. 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.
• •9. 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.
• •10. Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy)
• •11. 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.
• •12. Major surgery within 4 weeks with unhealed wounds or planned surgery during study
• •13. Concomitant use of drugs or substances affecting activity or pharmacokinetics of investigational products
• •14. Hypersensitivity to any component of study drugs
• •15. Chronic or concurrent immunosuppressive therapy, except Inhaled/topical steroids
• •16. Medical/psychiatric/social conditions compromising protocol compliance
• •17. Pregnancy, lactation, or refusal of contraception during and for 5 months post-treatment
• •18. Inability to undergo PET/CT or oral drug administration
• •1. Failure to complete ≥12 months of first-line PD-1/PD-L1 + VEGFR-TKI therapy due to unmanageable toxicity or other reasons
• •2. Failure to achieve CMR or PMR on PET/CT within 24 months after combination therapy; new metastatic lesions or disease progression on PET/CT.
• •3. Poor risk as per International Metastatic RCC Database Consortium (IMDC) criteria
• •4. ECOG performance status \>1
• •5. Karnofsky Performance Status (KPS) \<70%
• •6. Inadequate organ and bone marrow function
• •7. Uncontrolled hypertension (\>150/100 mmHg despite optimal therapy)
• •8. Uncontrolled comorbidities 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.
• •9. Medical/psychiatric/social conditions compromising protocol compliance
• •10. Pregnancy, lactation, or refusal of contraception during study period.
• •11. Inability to undergo PET/CT or oral drug administration
• •Withdrawal Criteria:
• •1. Disease progression with unsatisfactory efficacy, or occurrence of intercurrent illnesses during treatment or follow-up period.
• •2. Occurrence of severe treatment-related adverse reactions.
• •3. Laboratory test results indicating critical safety values.
• •4. Voluntary withdrawal of informed consent by the patient.
• •5. Investigator's judgment that withdrawal is in the subject's best interest.
• •6. Pregnancy during the trial period.
• •8. Poor patient compliance.
• •9. Loss to follow-up or death during the trial period.