Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
- Sponsor
- RenJi Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Objective Tumor Response Rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Neoadjuvant arm
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Intervention: Toripalimab
Neoadjuvant arm
Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Intervention: Axitinib
Outcomes
Primary Outcomes
Objective Tumor Response Rate
Time Frame: 3 month
Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors
Secondary Outcomes
- Safety assessed by adverse events(through study completion, an average of 4 months)
- Perioperative complication rate(from perioperative to 90 days after surgery)
- Quality of Life questionnaire(Baseline, 3 weeks, 12 weeks and after surgery)
- Tumor complexity changing by total R.E.N.A.L. score(Baseline, 12 weeks)