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Study on MRD Prediction of Efficacy of Toripalimab in the Treatment of High-risk Recurrent Renal Carcinoma

2026年6月15日 更新者：Tianjin Medical University Second Hospital

Predictive Value of Minimal Residual Disease for Efficacy of Toripalimab in High-risk Recurrent Renal Cell Carcinoma Following Nephrectomy: A Prospective Single-arm Study

This is a prospective cohort study aimed at clarifying the predictive value of MRD for postoperative DFS and OS in high-risk recurrent renal cell carcinoma patients who have undergone radical nephrectomy and received adjuvant treatment with Toripalimab. Further differentiating patients who need adjuvant immunotherapy.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The study population is high-risk recurrent renal cell carcinoma patients who have undergone radical nephrectomy and meet the criteria of ECOG Score 0-1, no residual tumor on imaging. The study subjects will undergo MRD testing about 3 weeks after surgery, and the drug will be started within 4 weeks of surgery. Imaging (CT, MRI) will be performed from the first dose of Toripalimab, every 12 weeks, and DFS will be evaluated. Survival will be recorded every 3 months. The study aims to investigate the predictive value of MRD technology for DFS and OS in these patients after surgery and provide reference for distinguishing patients who need adjuvant immunotherapy.

研究类型

观察性的

注册 (估计的)

110

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300211
        • 招聘中
        • Changyi Quan
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Participants with high-risk recurrent renal cell carcinoma after radical nephrectomy who are older than 18 years of age must have a clear pathological diagnosis and meet all enrollment criteria. The subjects voluntarily join the study and have good compliance with safety and survival follow-up.

描述

  1. There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components.
  2. On the day of signing the informed consent form, both males and females must be at least 18 years old.
  3. The participants provide written informed consent for the trial before enrollment.

  4. Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status.

    1. High risk RCC

      • pT4, Any Gr. N0, M0
      • pT Any stage, Any Gr., N+, M0
    2. M1 NED RCC (participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at the time of nephrectomy)
  5. No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed.
  6. Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin.
  7. It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases.
  8. Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
  9. Non-surgical sterilization or female participants of childbearing potential who are required to use a medically approved contraceptive method (such as an IUD, contraceptive pill or condom) during the study treatment period and for 3 months after the end of the study treatment period; Serum or urine HCG tests must be negative for women of non-surgical sterilization or childbearing age within 7 days prior to study enrollment; And must be non-lactation period; Non-surgical sterilization or male patients of childbearing age who consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the end of the study treatment period.
  10. Vital organ function meets the following requirements (excluding use of any blood components and cell growth factors within 14 days) : normal bone marrow reserve function; Absolute neutrophil count (ANC)≥1500/µL, Platelets≥100 000/µL, Hemoglobin ≥5.6 mmol/L (9g/dL); Normal renal function or serum creatinine ≤1.5 mg/d and/or creatinine clearance ≥30 mL/min for participants with creatinine levels >1.5×institutional ULN; Normal liver function or Total bilirubin ≤1.5xULN, or direct bilirubin≤ULN for participants with total bilirubin levels >1.5×ULN; AST (SGOT) and ALT (SGPT) ≤2.5×ULN; International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
High risk recurrent renal cell carcinoma patients receiving treatment with Toripalimab
High risk recurrence renal cell carcinoma patients who have undergone radical surgery will begin receiving treatment with Toripalimab within 4 weeks after surgery.Toripalimab is administered intravenously once every 3 weeks for a maximum of 17 cycles (approximately 1 year) or until disease recurrence, unacceptable toxic effects, intercurrent illness preventing further administration of Toripalimab, decision by the investigator, a new cancer resulting in active treatment, pregnancy, or nonadherence to the protocol. Imaging (CT, MRI) tests will be performed 12 weeks after the initial dosing and every 12 weeks for 2 years.Definition of High risk of recurrence ：tumor stage 2 with nuclear grade 4 or sarcomatoid differentiation, tumor stage 3 or higher, regional lymph-node metastasis, regional lymph-node metastasis, or stage M1 with NED (M1 with no evidence of disease) (M1 NED, defined as resection of the primary tumor and solid, isolated, soft-tissue metastases).
药品：Toripalimab
Toripalimab is a newly developed recombinant humanized (with a degree of 97%) anti-PD-1 monoclonal antibody (Chinese patent authorization number CN104250302B, PCT patent publication number (WO2014/206107A1)), belonging to the human IgG4/Kappa subtype. A point mutation of proline (S228P) has been introduced at the serine protein site 228 in the IgG4 hinge region to increase antibody stability and reduce possible IgG4 Fab chain substitutions. It can specifically bind to PD-1 and effectively block the interaction between PD-1 and its ligands PD-L1 (i.e. B7-H1) and PD-L2 (i.e. B7-DC), thereby activating cytotoxic T lymphocytes, increasing lymphocyte proliferation, and cytokine secretion, especially IFN - γ. To achieve the goal of using the immune system to kill tumors.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Effect on the disease-free survival in the trial patients.
大体时间：Imaging (CT, MRI) was evaluated at 12 weeks after the first dose of Toripalimab and every 12 weeks. Until the tumor recurred or could not tolerate the side effects or the drug for 1 year.
The sample size was calculated based on the objective response rate reported in the previous literature, and the target assumption was that the recurrence rate was 30% at 2 years and that adjuvant therapy with Toripalimab would prevent 50% of relapses.
Imaging (CT, MRI) was evaluated at 12 weeks after the first dose of Toripalimab and every 12 weeks. Until the tumor recurred or could not tolerate the side effects or the drug for 1 year.

次要结果测量

结果测量
措施说明
大体时间
Effect on the overall survival in the trial patients.
大体时间：Imaging (CT, MRI) was evaluated 12 weeks after initial dosing and every 12 weeks until the tumor recurred or could not tolerate side effects or drugs for 1 year, and survival was recorded every 3 months.
The sample size was calculated based on the objective response rate reported in the previous literature, and the target assumption was that the recurrence rate was 30% at 2 years and that adjuvant therapy with Toripalimab would prevent 50% of relapses.
Imaging (CT, MRI) was evaluated 12 weeks after initial dosing and every 12 weeks until the tumor recurred or could not tolerate side effects or drugs for 1 year, and survival was recorded every 3 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Tianjin Medical University Second Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年4月1日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年6月15日

首先提交符合 QC 标准的

2026年6月15日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • MRD-RCC

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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