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

NCT04118855 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Neo-RCC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma

Keywords

neoadjuvant therapy; Toripalimab; axitinib; nephrectomy; partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Safety assessed by adverse events

  through study completion, an average of 4 months

• Perioperative complication rate

  from perioperative to 90 days after surgery

• Quality of Life questionnaire

  Baseline, 3 weeks, 12 weeks and after surgery

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

  Baseline, 12 weeks

Study Arms (1)

Neoadjuvant arm

EXPERIMENTAL

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

Drug: Toripalimab; Drug: Axitinib

Interventions

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

Also known as: anti-PD-1 monoclonal antibody

Neoadjuvant arm

Axitinib DRUG

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

Neoadjuvant arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

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

Shanghai, 200127, China

Location

Related Publications (1)

• Huang J, Wang Y, Xu F, Wang Z, Wu G, Kong W, Cheoklong NG, Tricard T, Wu X, Zhai W, Zhang W, Zhang J, Zhang D, Chen S, Lian Y, Chen Y, Zhang J, Huang Y, Xue W. Neoadjuvant toripalimab combined with axitinib in patients with locally advanced clear cell renal cell carcinoma: a single-arm, phase II trial. J Immunother Cancer. 2024 Jun 11;12(6):e008475. doi: 10.1136/jitc-2023-008475.

  PMID: 38862251 DERIVED

MeSH Terms

Interventions

toripalimab; spartalizumab; Axitinib

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: March 1, 2020
• Primary Completion: February 28, 2023
• Study Completion: March 31, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

CN (1)