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临床试验/NCT06882486
NCT06882486招募中不适用

Post-immunotherapy Nephrectomy for Metastatic Kidney Cancer After Complete or Major Response to Systemic Therapy

Institut Paoli-Calmettes1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
progression-free survival

研究概览

简要总结

In the current era of immune checkpoint inhibitors (ICI), the role and timing of nephrectomy remains unknown, particularly in cases of residual kidney disease after a major response at metastatic sites. In these cases, the rationale for a delayed nephrectomy is that it might achieve a long-term response. This strategy could allow some patients to discontinue treatment and maintain tumor response. Furthermore, this approach might provide a potentially curative option for patients with metastases that are managed with and responding to ICI.

Regarding the results of our first retrospective cohort data (showing that two thirds of patients are free from recurrence without systemic treatment after nephrectomy), we designed a non-comparative randomized phase II trial assessing progression-free survival of patients with complete response or major partial response after ICI-based treatment, operated on delayed nephrectomy with discontinuation of systemic therapy (experimental arm) and in patients managed with continuation of systemic therapy without nephrectomy (control arm).

In a de-escalation approach, this strategy may have sense to allow patients with an excellent response to immunotherapy to stop systemic treatment with a curative objective and a substantial impact from a medico-economic point of view.

详细描述

Patients with metastatic kidney cancer will be treated according to current first-line treatment guidelines.

Patients may be included in the study (by signing a consent form) and randomized if a complete response (CR) or metastatic partial response (mPR) (>75%) is achieved with immunotherapy-based systemic therapy.

In the centers participating in the ancillary study, patients in the experimental arm (arm A) will undergo renal MRI and PSMA PET (positron emission tomography) scan prior to nephrectomy.

Arm A patients will undergo nephrectomy (partial or enlarged, depending on technical possibilities and surgeon's discretion), after which systemic treatment will be discontinued.

Patients in arm B will not undergo surgery, and will continue their systemic treatment unchanged (interrupted in the event of toxicity, in accordance with current recommendations).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient aged ≥ 18 years
  • •Diagnosed with synchronous metastatic kidney cancer
  • •With primary tumor still in place (no primary cytoreductive nephrectomy)
  • •Having received systemic ICI immunotherapy-based combination therapy
  • •In CR or mPR (defined as >75% response in metastatic lesions from baseline) according to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), excluding the primary renal lesion.
  • •Signed consent to participate
  • •Affiliated to the national social security scheme or beneficiaries of such a scheme

排除标准

  • •Women who are or may become pregnant (without effective contraception) or who are breast-feeding.
  • •Person in an emergency situation or unable to give consent.
  • •An adult under legal protection (guardianship, curators or safeguard of justice),
  • •Inability to undergo medical follow-up for geographical, social or psychological reasons.
  • •Patients who have undergone prior cytoreductive nephrectomy
  • •Patients considering nephrectomy for symptomatic disease, but without major response (CR or mPR) in metastatic disease
  • •Patients with non-metastatic disease at diagnosis who have received ICI in a neo-adjuvant setting
  • •Patients with contraindications to surgery or ineligible for nephrectomy
  • •Patients not wishing to undergo nephrectomy
  • •Patients with end-stage renal disease

研究组 & 干预措施

nephrectomy

Experimental

delayed nephrectomy and discontinuation of systemic treatment

干预措施: nephrectomy (Procedure)

no nephrectomy

No Intervention

no nephrectomy and continuation of systemic treatment

结局指标

主要结局

progression-free survival

时间窗: 24 month

post-randomization progression-free survival

次要结局

  • Intraoperative and postoperative complications(30 days)
  • Overall survival(24 month)
  • Immunotherapy-related adverse events(24 months)

研究者

发起方
Institut Paoli-Calmettes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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