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Clinical trial

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

ID
Name
Neo-RCC
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.
Trial arms
Trial start
2020-03-01
Estimated PCD
2023-02-28
Trial end
2023-03-31
Status
Completed
Phase
Early phase I
Treatment
Toripalimab
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
Arms:
Neoadjuvant arm
Other names:
anti-PD-1 monoclonal antibody
Axitinib
5 mg by mouth twice each day for 12 weeks prior to nephrectomy
Arms:
Neoadjuvant arm
Size
20
Primary endpoint
Objective Tumor Response Rate
3 month
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-04-04

1 organization

1 product

1 drug

1 indication

Organization
Renji Hospital
Drug
PD-1 antibody
Indication
Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
Product
Axitinib