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

Inclusion Criteria:

• Has histologically confirmed diagnosis of localized and locally advanced stage renalcell carcinoma (RCC), with moderate to high recurrence risk

• Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC asdefined by the following pathological tumor-node-metastasis and Fuhrman gradingstatus:

1. Intermediate-high risk RCC: pT1b-T2, Grade 4 or sarcomatoid, N0, M0; pT3, AnyGrade, N0, M0;

2. High risk RCC: pT4, Any Grade N0, M0; pT Any stage, Any Grade, N+, M0 M1 NEDRCC participants who present not only with the primary kidney tumor but alsosolid, isolated, soft tissue metastases that can be completely resected at oneof the following: the time of nephrectomy (synchronous) or, ≤1 year fromnephrectomy (metachronous)

• Have adequate tissue for PD-L1 testing 0Has an Eastern Cooperative Oncology GroupPerformance Status (ECOG PS) score of 0 or 1

• Expected survival ≥ 12 months;

• Participants of childbearing potential must agree to use an adequate method ofcontraception, starting with the first dose of study treatment through 120 daysafter the last dose of study treatment

• Has adequate organ function

• Be able to understand and willing to sign the informed consent form

Exclusion Criteria:

• Patients with advanced/metastatic renal cell carcinoma (RCC) or non-clear cell renalcell carcinoma (nccRCC).

• Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4antibodies, or other agents specifically targeting T-cell co-stimulationcheckpoints, or small molecule anti-angiogenic drugs.

• Subjects who underwent major surgery or chemotherapy within 4 weeks prior to thefirst dose administration, or those with postoperative duration >12 weeks whoreceived major surgery/chemotherapy within 4 weeks before first dosing.

• Subjects with hypersensitivity to study drugs.

• Active hemorrhage, ulceration, intestinal perforation, bowel obstruction, oruncontrolled 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 inadulthood.

• 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 weeksprior 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 studydrug 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 radicalnephrectomy/partial nephrectomy under general anesthesia.

• Pregnant/lactating women.

• Other conditions affecting trial conduct or interpretation (e.g., severe psychiatricdisorders).