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

Phase II Study of 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.

Study Overview

• Status: Completed
• Conditions: Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
• Intervention / Treatment: Drug: Axitinib; Drug: Toripalimab

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant arm; Patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.	Drug: Axitinib; 5 mg by mouth twice each day for 12 weeks prior to nephrectomy; Drug: 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; Other Names: anti-PD-1 monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Tumor Response Rate	Number of patients achieving a complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors	3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by adverse events	Safety as assessed by number of participants experiencing adverse events	through study completion, an average of 4 months
Perioperative complication rate	Perioperativecomplications judged by Clavien-Dindo classification	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	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.	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: axitinib; neoadjuvant therapy; nephrectomy; Toripalimab; partial nephrectomy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: Neo-RCC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes