NCT06138496已完成2 期
A Single-Arm Phase II Clinical Study Evaluating the Efficacy and Safety of Cadonilimab Combined With Lenvatinib as Neoadjuvant Therapy in Renal Cell Carcinoma Patients With Partial Nephrectomy Indications But High Surgical Risk
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年9月1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
- 已完成
- 发起方
- 入组人数
- 39
- 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 Cadonilimab and Lenvatinib, 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 (tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75% or tumors >7 cm)
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 provision of written informed consent prior to any study-related procedures.
- •Age ≥18 years at the time of enrollment; no restriction on sex.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Estimated survival ≥3 months.
- •Pathological confirmation of clear cell RCC or predominantly clear cell renal cell carcinoma by preoperative needle biopsy.
- •Patient willingness to undergo nephron-sparing surgery.
- •Presence of indications for nephron-sparing surgery but with high surgical complexity: 1) tumors measuring 4-7 cm located at the renal hilum or with endophytic growth ≥75%; or 2) tumors >7 cm.
- •At least one measurable lesion per RECIST v1.1 criteria, suitable for repeated accurate measurement.
- •Adequate organ function, with laboratory results during the screening period meeting all of the following criteria:
- •Hematology (no blood component or colony-stimulating factor support permitted within 2 weeks prior to treatment initiation):
- •Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L (≥1,500/mm³)
- •Platelet count (PLT) ≥100 × 10⁹/L (≥100,000/mm³)
- •Hemoglobin (Hb) ≥90 g/L
- •Hepatic function:
- •Serum total bilirubin (TBIL) ≤1.5 × ULN
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN
- •Serum albumin (ALB) ≥28 g/L
- •Coagulation:
- •- International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 × ULN
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory assessments, and all other study requirements.
排除标准
- •Patients meeting any of the following criteria will be ineligible for participation:
- •Lymph node metastasis
- •Tumor encasing the renal artery
- •Tumor thrombus within the renal vein
- •Diffuse tumor growth without a clear boundary with normal renal parenchyma
- •Poor general condition precluding tolerance of general anesthesia based on anesthesiological assessment
- •Severe cardiovascular or cerebrovascular disease, uncontrolled hypertension, or uncontrolled diabetes mellitus
- •Long-term use of immunosuppressive agents following organ transplantation
- •Current use of immunosuppressive medications
- •Active or clinically apparent infection or fever
- •T-cell lymphoma or multiple myeloma
- •Concurrent other malignancies, currently undergoing treatment for other benign or malignant tumors, or a history of other malignancies within the preceding 6 months
- •Metastatic renal cell carcinoma
- •Receipt of traditional Chinese herbal medicines with antitumor indications or immunomodulatory agents within 14 days prior to the first dose of study drug
- •Ongoing systemic therapy (including thymosin, interferon, or interleukins; local use for control of pleural effusion is permitted)
- •Active or potentially relapsing autoimmune disease; the following conditions are exempt: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism secondary to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type 1 diabetes mellitus requiring only stable-dose insulin replacement therapy
- •Concurrent enrollment in another clinical study, unless it is an observational/non-interventional study or the follow-up phase of an interventional study
- •Known history of psychiatric illness, substance abuse, alcohol dependence, or illicit drug use
- •Pregnant or breastfeeding women
- •Any concurrent disease, prior treatment, or laboratory abnormality that may confound study results, interfere with the subject's full study participation, or indicate that participation may not be in the subject's best interest
研究组 & 干预措施
Cadonilimab combined with Lenvatinib as neoadjuvant therapy
Experimental
干预措施: Cadonilimab Combined With Lenvatinib (Drug)
结局指标
主要结局
ORR
时间窗: Evaluation at the end of Cycle 3 or 6 (each cycle is 14 days) of Cadonilimab treatment
Objective Response Rate (ORR) based on RECIST 1.1 criteria.
次要结局
- Major Pathological Response rate (MPR)(The evaluation was conducted 5 days after surgery.)
- Nephron-sparing surgery (NSS) success rate(Evaluation at the end of surgery.)
- R0 resection rate(The evaluation was conducted 5 days after surgery.)
- Surgical complication rate(From the end of surgery to three months after surgery)
- Drug safety profile(During the treatment of combination of Cadonilimab and Lenvatinib.)
研究者
ZHOU FANGJIAN
Professor
Sun Yat-sen University
研究点 (1)
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