Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
- Conditions
- Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
- Interventions
- Registration Number
- NCT04118855
- Lead Sponsor
- RenJi Hospital
- Brief Summary
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.
- Detailed Description
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. Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then will receive partial or radical nephrectomy after neoadjuvant therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neoadjuvant arm Toripalimab Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Neoadjuvant arm Axitinib Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
- Primary Outcome Measures
Name Time Method Objective Tumor Response Rate 3 month Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
- Secondary Outcome Measures
Name Time Method Safety assessed by adverse events through study completion, an average of 4 months Safety as assessed by number of participants experiencing adverse events
Perioperative complication rate from perioperative to 90 days after surgery Perioperativecomplications judged by Clavien-Dindo classification
Quality of Life questionnaire Baseline, 3 weeks, 12 weeks and after surgery Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire
Tumor complexity changing by total R.E.N.A.L. score Baseline, 12 weeks R.E.N.A.L. Nephrometry Score) to quantify the anatomical characteristics of renal R.E.N.A.L. score consists of 5 anatomical features, and sum them up.
Trial Locations
- Locations (1)
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
🇨🇳Shanghai, China