This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer. Further evaluate whether the treatment plan is beneficial to the patient's surgery.
This is a phase II study to determine the efficacy and safety of Pembrolizumab when given in combination with Lenvatinib as treatment for patients with the advanced kidney cancer . Further evaluate whether the treatment is beneficial to operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. Additional 17 cycles of Pembrolizumab were needed for patients with high risk of recurrence (tumor stage 2 with nuclear grade IV or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, or stage M1 with no evidence of disease residual).
Changyi Quan
Tianjin, Tianjin Municipality, China
Tumor responses
All patients had imaging (enhanced CT, enhanced MRI or both ) before and after treatment to evaluate radiographic response within the primary tumor and venous tumor thrombus by using RECIST (Response Evaluation Criteria in Solid Tumors)
Time frame: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).
Adverse events
Adverse events were monitored throughout treatment until 30 days after surgery and were evaluated according to Common Terminology Criteria for Adverse Events (version 5.0).
Time frame: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).
Tumor viability assessment
Densitometric measurement of tumor viability using a modification of the Choi criteria was performed to evaluate the effect. Briefly, using axial source computed tomography images (1.5 mm thickness) a three-dimensional image of the kidney was reconstructed with an imaging workstation (Terra Recon, San Mateo, CA).
Time frame: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).
Progression free survival
Progression free survival was assessed by imaging (enhanced CT, enhanced MRI or both ) after surgery every 12 weeks until 12 months.
Time frame: Every 12 weeks until 12 months after surgery
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