Neoplasms Clinical Trial
Official title:
Phase II Trial of Neoadjuvant Immune-based Combinations in Patients Undergoing Nephrectomy for Locally Advanced ccRCC
The objective of this single-center clinical trial was to evaluate the objective response rate and safety of Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib) in neoadjuvant treatment of(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma.
Status | Recruiting |
Enrollment | 32 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Imaging is consistent with(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma - Puncture pathological biopsy was consistent with clear cell renal cell carcinoma - Subjects were to undergo radical nephrectomy or partial nephrectomy or enucleation of renal tumor - ECOG 0-1 points -Normal hematopoietic and organ function -- - Understand and plan visits, treatments, laboratory tests, and other research procedures. Exclusion Criteria: - Prior systemic anti-tumor treatment for RCC - Patients who are receiving any other investigational agents. - Clinical status indicating that immediate surgery (within 6 weeks) iswarranted regardless of whether neoadjuvant therapy is to beadministered, as assessed by the treating surgeon. - Inability to undergo baseline tumor biopsy. - Active or prior documented autoimmune or immunocompromisingconditions. - Uncontrolled hypertension - In the investigator's judgment, the subject has a medical history or current evidence of any disease, treatment, or laboratory abnormality that could confuse the results of the trial, interfere with the subject's participation throughout the trial, or is not in the subject's best interest to participate in the trial. |
Country | Name | City | State |
---|---|---|---|
China | Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate of neoadjuvant treatment of (T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma with Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib). | Tumor response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). | week 12 of neoadjuvant treatment | |
Secondary | Safety of neoadjuvant treatment of clear cell renal cell carcinoma with Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib). | Safety as assessed by number of participants experiencing adverse events. | up to 90 days after end of treatment | |
Secondary | Marginal negative (R0) rate of (T2a-T4NanyM0 or TanyN1M0)clear cell renal cell carcinoma treated with Toripalimab combined with TKI (Lenvatinib). | Marginal negative (R0) rate as assessed by number of participants experiencing Marginal negative (R0). | Baseline to date of surgery | |
Secondary | Disease-free survival (DFS) in(T2a-T4NanyM0 or TanyN1M0) clear cell renal cell carcinoma treated with Toripalimab combined with tyrosine kinase inhibitors TKI (Lenvatinib) neoadjuvant therapy. | DFS was defined as the time from date of surgery to disease recurrence or death whichever occurred first. | Up to 5 years after surgery | |
Secondary | Change From Baseline in Myeloid-derived Suppressor Cells (MDSCs) in the Tumor | Tumor tissue was collected from study biopsies and surgical samples, and was used to assess mean MDSCs using immunohistochemistry. | Baseline to date of surgery | |
Secondary | Change From Baseline in Regulatory T-cells (Tregs) in the Tumor | Tumor tissue was collected from study biopsies and surgical samples, and was used to assess mean Tregs using immunohistochemistry. | Baseline to date of surgery | |
Secondary | Change From Baseline in CD4+ T-cells in the Tumor | Tumor tissue was collected from study biopsies and surgical samples, and was used to assess mean CD4+ T-cells using immunohistochemistry. | Baseline to date of surgery | |
Secondary | Change From Baseline in CD8+ T-cells in the Tumor | Tumor tissue was collected from study biopsies and surgical samples, and was used to assess mean CD8+ T-cells using immunohistochemistry. | Baseline to date of surgery | |
Secondary | Change From Baseline in Ratio of Type 1 to Type 2 Tumor Associated Macrophages in the Tumor | Tumor tissue was collected from study biopsies and surgical samples, and was used to assess mean ratio of Type 1 to Type 2 tumor associated macrophages using immunohistochemistry. | Baseline to date of surgery | |
Secondary | Change From Baseline of Selected Cytokines in Peripheral Blood | Cytokines measured in peripheral blood were soluble CD27 (sCD27), eotaxin, macrophage inflammatory protein 1b (MIP-1b), and soluble programmed cell death protein 1 (sPD-1). | Baseline to Day 43 |
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