NCT07389629招募中2 期
The Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cancer With Partial Nephrectomy Indications But High Surgical Risk：A Single Arm, Phase II Clinical Study
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年11月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Decline rate of tumor R.E.N.A.L score
研究概览
简要总结
Through the combination of aparolitovorelli monoclonal antibody and lenvatinib neoadjuvant therapy, partial nephrectomy can be successfully and safely performed in patients with localized renal cell carcinoma (T1N0M0 or T2N0M0) who have indications for kidney preservation surgery but have difficulty in preserving the kidney (R.E.N.A.L. score >= 10).
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
- •Voluntarily sign a written informed consent form (ICF).
- •Age at the time of enrollment is >= 18 and under 80 years old, with no gender restrictions.
- •The physical fitness score of the Eastern Cooperative Oncology Group (ECOG) in the United States is 0 or 1;
- •Expected survival period >= 3 months.
- •Preoperative biopsy pathology confirmed 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;
- •Indications for kidney preservation surgery are available, but limited renal cancer with high difficulty of kidney preservation surgery (stage T1N0M0 or T2N0M0, must meet R.E.N.A.L. score >= 10);
- •At least one measurable lesion (according to mRECIST v1.1 standard) that is suitable for repeated and accurate measurements.
- •Good organ function, screening laboratory test results meet the following criteria: (1) 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 × 10^9/L (1500/mm^3); b. Platelet count (PLT) >= 100 × 10^9/L (100000/mm^3); c. Hemoglobin (HB) >= 90 g/L; (2) Liver: a. Serum total bilirubin (TBIL) <= 1.5 × ULN; b. Alanine transaminase (ALT) and aspartate transaminase (AST) <= 2.5 × ULN; For subjects with liver metastases, AST and ALT are <= 5 × ULN, while serum albumin (ALB) is >= 28g/L. Coagulation function: international normalized ratio (INR) and activated partial thromboplastin time (APTT) are <= 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
- •lymph node metastasis;
- •The tumor surrounds the renal artery;
- •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
Iparomlimab and Tuvonralimab (QL1706) combined with Lenvatinib as neoadjuvant therapy
Experimental
Lenvatinib Treatment Lenvatinib (8mg [body weight < 60 kg] or 12 mg [body weight ≥ 60 kg]) orally once daily, with or without food.
Intravenous Infusion of QL1706(Injection) Infuse QL1706 at a dose of 5mg/kg intravenously every three weeks, constituting one treatment cycle, a total of 2 or 4 cycles.
干预措施: QL1706 Combined With Lenvatinib (Drug)
结局指标
主要结局
Decline rate of tumor R.E.N.A.L score
时间窗: Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment
次要结局
- ORR(Evaluation at the end of Cycle 2 or 4 (each cycle is 21 days) of QL1706 treatment)
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University
研究点 (1)
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