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Completed

NCT Number: NCT04118855

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

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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Key information

Conditions

Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toripalimab

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

Other names: anti-PD-1 monoclonal antibody

Axitinib

Drug

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

Primary outcomes

  1. Objective Tumor Response Rate

    Time frame: 3 month

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

Secondary outcomes

  1. Safety assessed by adverse events

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

    Safety as assessed by number of participants experiencing adverse events

  2. Perioperative complication rate

    Time frame: from perioperative to 90 days after surgery

    Perioperativecomplications judged by Clavien-Dindo classification

  3. Quality of Life questionnaire

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

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

  4. Tumor complexity changing by total R.E.N.A.L. score

    Time frame: Baseline, 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2019
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.