A Prospective Single-arm Clinical Study of Pembrolizumab Combined With Lenvatinib Neoadjuvant Therapy in Patients With Advanced Renal Cance
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab plus Lenvatinib
- Conditions
- Renal Cell Carcinoma
- Sponsor
- Tianjin Medical University Second Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Tumor responses
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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 operation. Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery.
Detailed Description
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 operation.Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles pre-operation and patients need to continue taking the drug for a year after surgery. The main objective of the study was to evaluate whether the treatment was beneficial to patients undergoing surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to provide written informed consent
- •Age ≥ 18 years and age ≤75years
- •Patients with pathologically and radiographically confirmed renal cell carcinoma: Clinical staging:cT3N0-1M0-1,cT4N0-1M0-1(III/IV stage)
- •Preoperative imaging evaluation can be performed radical excision or tumor reduction surgery
- •There are no suspected brain metastases
- •The presence of measurable lesions was assessed according to RECISTv1.1 criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- •Organ function level must meet the following requirements:
- •Hematological indexes: neutrophil count \>= 1.5x10\^9/L, platelet count \>= 100x10\^9/L, hemoglobin \>= 9.0 g/dl (can be maintained by blood transfusion); Liver function: total bilirubin \<=1.5 ULN, alanine aminotransferase and aspartate aminotransferase \<=1.5 ULN
- •Women were required to use an effective contraceptive method for three months after the end of the study, and men were required to consent to use an effective contraceptive method with their spouse during and for three months after the end of the study
Exclusion Criteria
- •Prior treatment with radiation, chemotherapy, long-term or high-dose hormone therapy, or immune checkpoint inhibitors
- •Previous or concurrent other malignancy
- •Previous PD-L1 or PD-L1 treatment, or allergy to PD-L1
- •History of primary immunodeficiency
- •Active, known or suspected autoimmune diseases
- •Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- •Pregnant or lactating female patients;
- •Untreated acute or chronic active hepatitis B or hepatitis C infection. Under the condition of monitoring the virus copy number of patients receiving antiviral treatment, doctors can judge whether they are in line with the patients' individual conditions;
- •Have a clear history of active tuberculosis;
- •Participating in other clinical researchers;
Arms & Interventions
Advanced RCC (Locally advanced, regional LN invaded, or M1-NED)
Patients will receive treatment with Pembrolizumab in combination with Lenvatinib every 3 weeks for 3 cycles in the preoperation. In addition, 17 cycles' 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).
Intervention: Pembrolizumab plus Lenvatinib
Outcomes
Primary Outcomes
Tumor responses
Time Frame: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).
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)
Adverse events
Time Frame: Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).
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).
Secondary Outcomes
- Progression free survival(Every 12 weeks until 12 months after surgery)
- Tumor viability assessment(Through treatment completion (before surgery), an average of 3 cycles (each cycle is 21 days).)