A Study on the Safety and Effectiveness of Tislelizumab Combined With Axitinib for Neoadjuvant Treatment of ccRCC

NCT05172440 | Unknown Phase 2

• 1 other identifier: IUNU-RC-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single-center clinical trial to evaluate the tumor shrinkage and safety of tislelizumab combined with axitinib in Neoadjuvant therapy of T2-T3N0M0 renal clear cell carcinoma

Conditions

Neoadjuvant Therapy

Keywords

ccRCC; Neoadjuvant therapy; tislelizumab; axitinib

Outcome Measures

Primary Outcomes (1)

• Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma

  Objective response rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma

  7 days before surgery

Secondary Outcomes (4)

• The safety of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma

  Follow-up period

• Two-year disease-free survival (DFS) of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma

  Three months to 2 years after surgery

• Explore biomarkers in tumor tissue and blood that may be related to the efficacy of neoadjuvant therapy and the prognosis of subjects

  Three months to 2 years after surgery

• The downgrading rate of tislelizumab combined with axitinib in neoadjuvant treatment of T2-T3N0M0 renal clear cell carcinoma

  Three months to 2 years after surgery

Study Arms (1)

therapy group

EXPERIMENTAL

Subjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later.

Drug: tislelizumab combined with axitinib

Interventions

tislelizumab combined with axitinib DRUG

Subjects received axitinib 5 mg bid, 12 weeks, and tislelizumab 200 mg on the first day of the first week, 4th week, 7th week, and 10th week, and intravenous infusion. With 21 days as a treatment cycle, 4 cycles of treatment, namely 12 weeks. Axitinib was discontinued for 12 weeks after the completion of treatment, and surgery was performed 7 days later.

therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old
• Imaging is consistent with T2-T3N0M0 renal cell carcinoma
• Needle pathological biopsy is consistent with renal clear cell carcinoma
• The subject intends to undergo radical nephrectomy or partial nephrectomy or renal tumor enucleation
• ECOG 0-1 points
• Normal hematopoiesis and organ function
• Hematopoietic function (no blood transfusion or blood products, no use of hematopoietic stimulating factors or other drugs to correct blood cells within 2 weeks before the first trial medication):
• Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet ≥100×109/L; Hemoglobin ≥9.0g/dL or ≥5.6mmol/L.
• Kidney function:
• Serum creatinine ≤ 1.5 times ULN, or serum creatinine\> 1.5×ULN, the creatinine clearance rate is 60 mL/min; liver function: Total bilirubin≤1.5×ULN or total bilirubin\>1.5×ULN but direct bilirubin is normal; AST and ALT≤2.5×ULN;
• Coagulation:
• International normalized ratio (INR) or prothrombin time (PT)≤1.5×ULN, and the activated part Thromboplastin time (aPTT)≤1.5×ULN; Left ventricular ejection fraction (LVEF) ≥50%
• Able to sign informed consent
• During the entire study period and within 3 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures and not to donate sperm;
• Understand and conduct visits, treatments, laboratory tests, and other research procedures as planned.

You may not qualify if:

• Previously received anti-tumor immunotherapy, including but not limited to cytokines (IL-2, IFN-α, etc.) and antibody drugs (anti-PD-1, PD-L1 or CTLA-4 antibodies, etc.);
• Have previously received drug treatments targeting VEGF, VEGFR or mTOR, including but not limited to sunitinib, axitinib, sorafenib, pezopanib, cabotinib, lenvatinib, Bevacizumab or Iverolimus, etc.;
• Participated in or currently participating in an experimental drug trial within 4 weeks before the first trial drug administration, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study; major surgery within 4 weeks before the first trial drug administration (Judgment by the investigator) or in the recovery period of surgery.
• Receive Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks before the administration of the first trial. Adrenal cortex hormones (\>10 mg prednisone or equivalent drugs per day) or other immunosuppressive system treatments are required within 2 weeks before the first trial administration; those with \>10 mg prednisone or equivalent drugs per day Inhalers, but those without active autoimmune diseases can participate in this study;
• There are other malignant tumors that have progressed or need to be treated in the 5 years before enrollment (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of breast, cervix or prostate);
• There is a history of central nervous system (CNS) metastasis or the baseline imaging (MRI or CT) examination within 30 days before the first trial administration shows CNS metastasis;
• Hypertension with poor control (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg) with a single drug;
• The following cardiovascular events occurred in the 6 months before enrollment:
• Myocardial infarction
• Unstable angina
• Cardiovascular angioplasty or stent implantation
• Coronary artery/peripheral artery bypass grafting
• Grade III or IV congestive heart failure specified by the New York Heart Association
• Cerebrovascular accident or transient ischemic attack
• QT interval (QTc) ≥480 msec corrected by heart rate (Bazett's formula);

Sponsors & Collaborators

• Hongqian Guo: lead

Study Sites (1)

Hongqian Guo

Nanning, Jiangsu, China

Location

MeSH Terms

Interventions

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 Officials

• shun zhang, Dr.

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: December 29, 2021
• Study Start: December 9, 2021
• Primary Completion: November 20, 2023
• Study Completion: October 1, 2024
• Last Updated: December 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)