Phase II Single-arm Clinical Study of the Efficacy and Safety of Pucotenlimab in Combination With Vorolanib Neoadjuvant Therapy for Patients With High-risk Renal Carcinoma Indicating Partial Nephrectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) based on RECIST 1.1 criteria.
研究概览
简要总结
Through the neoadjuvant treatment with a combination of Pucotenlimab and Vorolanib, it enabled the successful and safe implementation of partial nephrectomy in patients with localized renal cancer, who had indications for nephron-sparing surgery but faced considerable difficulty in preserving the kidney (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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign a written informed consent form (ICF).
- •Age at the time of enrollment is between 18 years old and 85 years old, regardless of gender.
- •The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or
- •Expected survival period ≥ 3 months.
- •Preoperative biopsy pathology confirms renal clear cell carcinoma or renal cell carcinoma mainly composed of clear cell carcinoma
- •ECOG score 0 or 1
- •The patient is willing to undergo kidney preservation surgery
- •Preoperative assessment of healthy kidney GFR<60 ml/min through renal dynamic imaging
- •There are indications for kidney preservation surgery, but the surgery is difficult [① 4-7cm tumor located at the renal hilum or endogenous ≥ 75% (T1bN0M0); ② Tumors larger than 7cm (T2N0M0)]
- •There should be at least one measurable lesion (according to mRECIST v1.1 criteria) that is suitable for repeated and accurate measurements.
- •Good organ function, laboratory test results during the screening period meet the following criteria:
- •Hematology (no blood components or cell growth factors are allowed to support treatment within 2 weeks before starting treatment):
- •a. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); b. Platelet count (PLT) ≥ 100 × 109/L (100000/mm3); c. Hemoglobin (HB) ≥ 90 g/L;
- •Serum total bilirubin (TBIL) ≤ 1.5 × ULN;
- •Alanine transaminase (ALT) and aspartate transaminase (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
- •The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study.
排除标准
- •Renal vein cancer thrombus
- •Diffuse tumor growth, with no clear boundary from normal renal parenchyma
- •General poor condition, anesthesia assessment cannot tolerate general anesthesia surgery
- •Have serious cardiovascular and cerebrovascular diseases, uncontrollable
- •hypertension and diabetes
- •Patients who have long-term use of immunosuppressants after organ transplantation
- •Patients who are currently using immunosuppressive drugs
- •Patients with clear infection or fever
- •Patients with T-cell lymphoma and myeloma
- •Patients who have concurrent malignant tumors, are currently undergoing treatment for other benign or malignant tumors, or have a history of other malignant tumors within the past six months
- •Metastatic renal cell carcinoma.
- •Received Chinese herbal medicine or immunomodulatory drugs with anti-tumor indications within 14 days prior to the first use of the investigational drug
- •Perform systematic treatment (including thymosin, interferon, interleukin, except for local use to control pleural effusion).
- •Suffering from active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.
- •Simultaneously enrolled in another clinical study, unless it is an observational, non interventional clinical study or a follow-up period of an interventional study.
- •Known history of mental illness, drug abuse, alcoholism, or drug use.
- •Pregnant or lactating women.
- •Any past or current illness, treatment, or laboratory test abnormalities may confuse the research results, affect the full participation of the subjects in the study, or participation in the study may not be in the best interests of the subjects.
研究组 & 干预措施
Pucotenlimab combination with Vorolanib as neoadjuvant therapy
Vorolanib Treatment Vorolanib 200mg orally once daily, with or without food.Intravenous Infusion of Pucotenlimab(Injection) Infuse Pucotenlimab at a dose of 200mg intravenously every three weeks, constituting one treatment cycle, the maximum duration of treatment should not exceed 4 cycles.Perform imaging evaluation after 2 cycles, including renal CT plain scan+enhancement, measurement of tumor volume, and evaluation of ORR. If PD is detected in the first imaging assessment, the study will be terminated. According to the current diagnosis and treatment routine, communicate with the patient about the follow-up treatment plan:Radical nephrectomy; Utilization of other targeted therapies; Combination targeted therapy with immunotherapy. If the tumor shrinks significantly and the surgeon evaluates that partial nephrectomy can be safely performed, drug therapy should be stopped and partial nephrectomy should be performed; otherwise, continue treatment to 4 cycles before surgery.
干预措施: Pucotenlimab combination with Vorolanib (Drug)
结局指标
主要结局
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
时间窗: Evaluation at the end of Cycle 2 or Cycle 4 (each cycle is 21 days) of Pucotenlimab treatment
次要结局
未报告次要终点
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University