Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Conditions
Keywords
neoadjuvant therapy, Toripalimab, axitinib, nephrectomy, partial nephrectomy
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.
Interventions
DRUGToripalimab
240mg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses prior to partial nephrectomy or radical nephrectomy
DRUGAxitinib
5 mg by mouth twice each day for 12 weeks prior to nephrectomy
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed