Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma Clinical Trial
Official title:
Phase II Study of Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
| Verified date | April 2023 |
| Source | RenJi Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | March 31, 2023 |
| Est. primary completion date | February 28, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| RenJi Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Objective Tumor Response Rate | Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors | 3 month | |
| Secondary | Safety assessed by adverse events | Safety as assessed by number of participants experiencing adverse events | through study completion, an average of 4 months | |
| Secondary | Perioperative complication rate | Perioperativecomplications judged by Clavien-Dindo classification | from perioperative to 90 days after surgery | |
| Secondary | Quality of Life questionnaire | Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire | Baseline, 3 weeks, 12 weeks and after surgery | |
| Secondary | Tumor complexity changing by total R.E.N.A.L. score | 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. | Baseline, 12 weeks |