Clinical trial · Interventional
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
- 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 design to prospectively investigate the safety and efficacy of Toripalimab combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the immune system by blocking the function of an inhibitory molecule, Programmed cell death-1 (PD-1). This is a single-institution, single-arm phase 2 clinical trial.
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 |
|---|---|---|---|
| Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib | Drug | Axitinib | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant arm
- description
- Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
- interventionNames
- Drug: Toripalimab
- Drug: Axitinib
Primary outcomes (1)
- measure
- Objective Tumor Response Rate
- timeFrame
- 3 month
- description
- Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
Secondary outcomes (4)
- measure
- Safety assessed by adverse events
- timeFrame
- through study completion, an average of 4 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Non-metastatic biopsy-proven clear cell renal cell carcinoma (T2-T3N0-1M0) * Schedule to undergo either partial or radical nephrectomy as part of treatment plan * ECOG performance status of 0 or 1 * Adequate organ and marrow function defined by study-specified laboratory tests * Agree to comply with scheduled visits, treatment plans, lab tests and other study procedures * Do not have any other cancers in the 5 yr preceding diagnosis of their renal cancer Exclusion Criteria: * Patients who have received other systems for anti-tumor treatment * Patients who have previously received targeted or immunotherapy * Need for urgent or emergent nephrectomy to relieve symptoms * Current use of immunosuppressive agents * Pregnant or breastfeeding women * History of autoimmune disease or syndrome
References
Publications (1)
- DERIVEDHuang J, Wang Y, Xu F, Wang Z, Wu G, Kong W, Cheoklong NG, Tricard T, Wu X, Zhai W, Zhang W, Zhang J, Zhang D, Chen S, Lian Y, Chen Y, Zhang J, Huang Y, Xue W. Neoadjuvant toripalimab combined with axitinib in patients with locally advanced clear cell renal cell carcinoma: a single-arm, phase II trial. J Immunother Cancer. 2024 Jun 11;12(6):e008475. doi: 10.1136/jitc-2023-008475. PMID 38862251