A Comparison of Vorolanib Tablets Combined With Everolimus Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed After Treatment With Immunotherapy Monotherapy or in Combination With TKI

Peking University Cancer Hospital & Institute

Status and phase: Not yet enrolling; Phase 3

Conditions: Renal Cell Carcinoma (RCC)

Treatments: Drug: Sunitinib; Drug: Vorolanib Tablets+Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT07165418

2025YJZ61

Details and patient eligibility

About

This study is a multicenter, open-label, randomized controlled trial that enrolled 116 patients with advanced or metastatic renal cell carcinoma who had failed first-line treatment with PD-1/PD-L1 monotherapy or VEGFR TKI combined with PD-1/PD-L1 therapy. Patients were randomly assigned in a 1:1 ratio to receive either the experimental group treatment with vorolanib tablets combined with everolimus or the control group treatment with sunitinib as second-line therapy until disease progression. The study aimed to evaluate the efficacy and safety of vorolanib tablets combined with everolimus as second-line therapy for renal cell carcinoma patients.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pathologically confirmed renal clear cell carcinoma (histological or cytological);
2. Subjects who have failed prior treatment with a single anti-PD-1/PD-L1 agent or a combination of anti-PD-1/PD-L1 and anti-VEGFR TKI;
3. Age 18 to 80 years;
4. Estimated survival exceeding 12 weeks;
5. KPS score ≥70;
6. At least one measurable lesion per RECIST 1.1 criteria, which has not received prior radiation therapy;
7. Adequate organ function levels;
8. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization; all enrolled subjects (male or female) must use effective barrier contraception throughout treatment and for 4 weeks post-treatment;
9. Subjects must be capable of understanding and voluntarily signing the informed consent form, which must be signed prior to any trial procedures.

Exclusion criteria

1. Patients who have received one or more prior systemic anticancer treatment regimens for clear cell renal cell carcinoma;
2. Patients who have not previously received immunosuppressive therapy for advanced renal cell carcinoma;
3. Subjects currently undergoing anticancer therapy (excluding local radiotherapy for bone metastases);
4. Subjects with known hypersensitivity to similar drugs;
5. Subjects with active infectious diseases;
6. Any uncontrolled clinical condition;
7. Undergone major surgery within 4 weeks prior to enrollment;
8. History of significant psychiatric disorders that may impair understanding of informed consent or compliance with the study protocol;
9. Any condition affecting the subject's ability to swallow medication;
10. Pregnant or lactating women;
11. Subjects with severe pulmonary disease, asthma, or COPD history, with pulmonary function tests indicating moderate or greater impairment;
12. Any other factors deemed by the investigator to make the subject unsuitable for participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 2 patient groups

Vorolanib Tablets+Everolimus

Experimental group

Treatment:

Drug: Vorolanib Tablets+Everolimus

Sunitinib

Active Comparator group

Treatment:

Drug: Sunitinib