A Single-arm Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease-Free Survival (DFS) as Assessed by Investigator
研究概览
简要总结
The goal of this clinical trial is to learn if the drug toripalimab (an anti-PD-1 antibody) works to prevent cancer recurrence in patients with high-risk renal cell carcinoma after they have had surgery to remove the kidney (nephrectomy). The study will also learn about the safety of toripalimab in this setting.The main questions the study aims to answer are:
- Does treatment with toripalimab after nephrectomy increase the time patients live without their cancer returning (disease-free survival) compared to what would be expected without this treatment?
- What medical problems (side effects) do participants have when receiving toripalimab? This is a single-arm study, meaning all participants in the trial will receive the study drug, toripalimab.. Researchers will monitor participants over time to see if the outcomes with toripalizumab are better than what is historically known for similar patients who only had surgery.
Participants in this study will:
- Receive toripalimab by intravenous (IV) infusion once every 3 weeks for up to about one year ( 17 doses).
- Visit the clinic regularly for check-ups, which will include:
Imaging scans (like CT or MRI) of the chest, abdomen, and pelvis every 12 weeks to check for cancer recurrence.
Blood and urine tests to monitor safety. Questionnaires about their quality of life and symptoms. Be followed for a long period after treatment ends to track overall survival and long-term health.
详细描述
- Study Background and Rationale Renal cell carcinoma (RCC) carries a substantial risk of recurrence post-nephrectomy, particularly in patients with intermediate-high risk, high risk, or M1 no evidence of disease (NED) status following metastasectomy. The phase III KEYNOTE-564 clinical trial demonstrated that adjuvant therapy with pembrolizumab, an anti-PD-1 antibody, significantly improved disease-free survival (DFS) compared to placebo in this patient population, establishing a new therapeutic standard. Building upon this landmark finding, the present study aims to investigate the efficacy and safety of toripalimab, another anti-PD-1 monoclonal antibody, within a similar clinical context. This single-arm, phase II trial seeks to evaluate whether toripalimab can provide comparable clinical benefits, including reduced recurrence risk and improved survival outcomes, for patients with high-risk RCC following complete surgical resection, while thoroughly assessing its safety profile.
- Study Objectives
Primary Objectives:
To evaluate the efficacy of adjuvant toripalimab as measured by investigator-assessed Disease-Free Survival (DFS) and Overall Survival (OS).
Secondary Objectives:
To assess the safety and tolerability profile of adjuvant toripalimab and patient-reported outcomes (PROs) using quality of life questionnaires.. 3. Trial Design and Methodology This is a single-center, prospective, single-arm, Phase II clinical trial. The design leverages the positive signal observed in the KEYNOTE-564 trial to explore the potential of a similar immunotherapeutic agent, toripalimab, in a real-world setting at a major academic center. The study will enroll patients who have undergone nephrectomy and are within the 4 to 12-week postoperative window. Treatment involves intravenous administration of toripalimab at a fixed dose of 240 mg every three weeks, for a planned treatment duration of approximately one year (17 cycles), mirroring the treatment schedule found effective in the precedent trial. Treatment will continue until disease recurrence, unacceptable toxicity, or other protocol-defined discontinuation criteria are met. The single-arm design is chosen to efficiently characterize the activity and safety of toripalimab in this specific adjuvant setting, with outcomes referenced against historical controls and the results of prior pivotal studies. 4. Study Procedures and Assessments
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High risk recurrent renal cell carcinoma patients receiving treatment with Toripalimab
Intervention: Toripalimab, a humanized anti-PD-1 monoclonal antibody. Dosage & Administration: Fixed dose of 240 mg via intravenous infusion every 3 weeks (Q3W). Treatment commences within 4-12 weeks post-nephrectomy.
Treatment Duration: Administered for up to 17 cycles (approximately one year), or until disease recurrence, unacceptable toxicity, or meeting other discontinuation criteria.
Dose Modification Policy: Dose adjustment is not permitted. Management of specific immune-related adverse events (irAEs) is strictly limited to therapy suspension (with potential resumption after symptom improvement to Grade 0-1) or permanent discontinuation, as per protocol-specified guidelines.
Key Assessments: Includes regular tumor imaging (CT/MRI) every 12 weeks, comprehensive safety monitoring, and quality of life evaluations.
干预措施: Toripalimab (Drug)
结局指标
主要结局
Disease-Free Survival (DFS) as Assessed by Investigator
时间窗: From enrollment until the first documented disease recurrence, distant metastasis, or death from any cause (whichever occurs first), assessed up to 60 months
Disease-Free Survival is defined as the time from enrollment to the first documented occurrence of any of the following events: Local recurrence of renal cell carcinoma (confirmed by imaging) Distant metastasis of renal cell carcinoma (confirmed by imaging) Death from any cause Participants without documented DFS events at the time of analysis will be censored at the date of their last tumor assessment. Tumor assessments will be performed using computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
次要结局
- Overall Survival (OS)(From enrollment until death from any cause, assessed up to 120 months)
- Incidence and Severity of Adverse Events(At the following predefined visit time points: first dose (baseline), each subsequent cycle treatment day, and the 90-day safety follow-up visit after the last dose.)
- Health-Related Quality of Life Assessment(Baseline, every 12 weeks during treatment (up to 17 cycles), at treatment discontinuation, and every 12 weeks during follow-up until disease recurrence (up to 60 months).)