Clinical trial NCT04118855: Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Keywords: neoadjuvant therapy
Toripalimab
axitinib
nephrectomy
partial nephrectomy
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective Tumor Response Rate
timeFrame: 3 month
Secondary outcomes:
measure: Safety assessed by adverse events
timeFrame: through study completion, an average of 4 months
measure: Perioperative complication rate
timeFrame: from perioperative to 90 days after surgery
measure: Quality of Life questionnaire
timeFrame: Baseline, 3 weeks, 12 weeks and after surgery
measure: Tumor complexity changing by total R.E.N.A.L. score
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
References: