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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2023-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant arm

Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.

Group Type EXPERIMENTAL

Toripalimab

Intervention Type DRUG

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

Axitinib

Intervention Type DRUG

5 mg by mouth twice each day for 12 weeks prior to nephrectomy

Interventions

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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

Intervention Type DRUG

Axitinib

5 mg by mouth twice each day for 12 weeks prior to nephrectomy

Intervention Type DRUG

Other Intervention Names

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anti-PD-1 monoclonal antibody

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No