NCT06129955尚未招募2 期
A Phase II Clinical Study on the Efficacy and Safety of Pucotenlimab Combined With Lenvatinib as a Neodjuvant Therapy for Non Clear Cell Renal Cell Carcinoma With Indications for Partial Nephrectomy But High Surgical Risk: A Single Arm Approach
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年11月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Through the neoadjuvant treatment with a combination of Pucotenlimab and Lenvatinib, it eventually enables the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who have indications for nephron-sparing surgery but face significant difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).
详细描述
Through the neoadjuvant treatment with a combination of Pucotenlimab and Lenvatinib, it eventually enables the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who have indications for nephron-sparing surgery but face significant difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signing of a written Informed Consent Form (ICF).
- •Age ≥18 and <80 years at the time of enrollment, regardless of gender.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Expected survival ≥3 months.
- •Preoperative biopsy confirming non-clear cell renal cancer.
- •Patient's willingness to undergo nephron-sparing surgery.
- •Have indications for nephron-sparing surgery but with high difficulty in kidney preservation (T1b with an endophytic component ≥75% or T2).
- •At least one measurable lesion (according to mRECIST v1.1 criteria) suitable for repeated and accurate measurements.
- •Good organ function, with screening laboratory results meeting the following criteria:
- •Hematology (no blood component or growth factor support therapy in the two weeks before treatment):
- •Absolute neutrophil count (ANC) ≥ 1.5×10^9/L (1,500/mm^3);
- •Platelet count (PLT) ≥ 100×10^9/L (100,000/mm^3);
- •Hemoglobin (HB) ≥ 90 g/L.
- •Hepatic function:
- •Total bilirubin (TBIL) ≤ 1.5×ULN;
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; for subjects with liver metastasis, AST and ALT ≤ 5×ULN.
- •Serum albumin (ALB) ≥ 28g/L.
- •Coagulation function:
- •International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- •· Willingness and ability of the subject to comply with the scheduled visits, treatment plan, laboratory tests, and other study requirements.
排除标准
- •Renal biopsy pathology diagnosis indicates collecting duct carcinoma.
- •Renal biopsy pathology diagnosis indicates chromophobe carcinoma.
- •Renal biopsy pathology indicates clear cell renal cell carcinoma or predominantly clear cell renal cell carcinoma.
- •Presence of lymph node metastasis.
- •Tumor encases the renal artery.
- •Intravascular tumor thrombus in the renal vein.
- •Tumor exhibits diffuse growth without distinct boundaries from normal renal parenchyma.
- •Poor general condition, unsuitable for tolerating general anesthesia surgery in anesthesia assessment.
- •Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, and diabetes.
- •Patients using long-term immunosuppressive agents after organ transplantation.
- •Patients currently using immunosuppressive drugs.
- •Patients with evident infection or fever.
- •Patients with T-cell lymphoma, myeloma.
- •Simultaneously having other malignant tumors, undergoing treatment for malignancies, or having a history of other malignant tumors within the past six months.
- •Metastatic renal cell carcinoma.
- •Received herbal or immune-modulating drugs with antitumor indications within 14 days before the first use of the investigational drug.
- •Undergoing systemic therapy (excluding thoracoscopic peptide, interferon, interleukin used for controlling pleural effusion locally).
- •Active or potential relapse of autoimmune diseases, except for cases not requiring systemic treatment such as stable vitiligo, alopecia, psoriasis, or eczema; hypothyroidism caused by autoimmune thyroiditis that requires stable hormone replacement therapy; Type I diabetes requiring stable insulin replacement therapy.
- •Concurrent participation in another clinical study unless it is an observational, non-interventional clinical study, or the follow-up period of an interventional study.
- •Known mental illness, substance abuse, alcoholism, or drug addiction history.
- •Pregnant or lactating women.
- •Past or current existence of any diseases, treatments, or laboratory abnormalities that might confound study results, affect the subject's full participation in the study, or participation that may not be in the subject's best interest.
研究组 & 干预措施
Pucotenlimab combined with Lenvatinib as neoadjuvant therapy
Experimental
Pucotenlimab combined with Lenvatinib as neoadjuvant therapy
干预措施: Pucotenlimab Combined With Lenvatinib (Drug)
结局指标
主要结局
ORR
时间窗: At the end of Cycle 6 (each cycle is 14 days) of Pucotenlimab treatment
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
次要结局
未报告次要终点
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University
研究点 (1)
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