Clinical trial · Interventional
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
A Multicenter, Randomized Controlled Study Comparing Vorolanib Tablets Plus Everolimus With Sunitinib in Patients With Advanced Renal Cell Carcinoma Who Have Progressed on Immunotherapy Monotherapy or in Combination With TKI
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma (RCC) | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunitinib | Drug | Sunitinib | ALIAS |
| Vorolanib Tablets+Everolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vorolanib Tablets+Everolimus
- interventionNames
- Drug: Vorolanib Tablets+Everolimus
- type
- ACTIVE_COMPARATOR
- label
- Sunitinib
- interventionNames
- Drug: Sunitinib
Primary outcomes (1)
- measure
- Progression Free Survival(PFS)
- timeFrame
- The time from study entry to the first disease progression (PD) or death .Estimate up to 2 years.
- description
- The time from study entry to the first disease progression (PD) or death from any cause, as assessed by the investigator.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available