Vorolanib Monotherapy or in Combination With Toripalimab as Adjuvant Therapy for Patients With Intermediate-high Risk of Recurrence in Renal Cell Carcinoma

Exclusion Criteria

• •Patients with advanced/metastatic renal cell carcinoma (RCC) or non-clear cell renal cell carcinoma (nccRCC).
• •Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies, or other agents specifically targeting T-cell co-stimulation checkpoints, or small molecule anti-angiogenic drugs.
• •Subjects who underwent major surgery or chemotherapy within 4 weeks prior to the first dose administration, or those with postoperative duration \>12 weeks who received major surgery/chemotherapy within 4 weeks before first dosing.
• •Subjects with hypersensitivity to study drugs.
• •Active hemorrhage, ulceration, intestinal perforation, bowel obstruction, or uncontrolled hypertension (defined as BP \>140/90 mmHg or unstable during screening).
• •Uncontrolled adrenal insufficiency.
• •Congenital/acquired immunodeficiency (e.g., HIV infection) or active hepatitis:
• •HBV: HBsAg+ with HBV DNA ≥2000 IU/mL (≥10⁴ copies/mL) HCV: Anti-HCV+ with viral load \>ULN
• •Active autoimmune diseases (including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) or history of autoimmune diseases. Exceptions: Vitiligo or childhood asthma fully resolved without intervention in adulthood.
• •Symptomatic visceral metastases with imminent life-threatening complications (e.g., uncontrolled exudation \[pleural/pericardial/abdominal\], lymphangitic carcinomatosis, or \>30% liver involvement).
• •Severe infections requiring IV antibiotics/antifungals/antivirals within 4 weeks prior to first dose, or unexplained fever \>38.5°C during screening.
• •History of other malignancies within 5 years.
• •Systemic corticosteroids or immunosuppressants within 14 days before first study drug administration.
• •Documented active tuberculosis (Mycobacterium tuberculosis).
• •Concurrent use of experimental agents or standard antineoplastic therapies.
• •Active infections.
• •High bleeding risk.
• •Comorbidities (e.g., cardiopulmonary insufficiency) precluding radical nephrectomy/partial nephrectomy under general anesthesia.
• •Pregnant/lactating women.
• •Other conditions affecting trial conduct or interpretation (e.g., severe psychiatric disorders).