Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma

RenJi Hospital20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Objective Tumor Response Rate

Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors

Time frame: 3 month

Secondary Outcomes

Safety assessed by adverse events

Safety as assessed by number of participants experiencing adverse events

Time frame: through study completion, an average of 4 months

Perioperative complication rate

Perioperativecomplications judged by Clavien-Dindo classification

Time frame: from perioperative to 90 days after surgery

Quality of Life questionnaire

Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI) -15 questionnaire

Time frame: Baseline, 3 weeks, 12 weeks and after surgery

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.

Time frame: Baseline, 12 weeks