RecruitingNot Applicable

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

China110 participantsStarted 2024-04-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Effect on the disease-free survival in the trial patients.

Timeframe: 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.

Trial details

NCT IDNCT07657325

SponsorTianjin Medical University Second Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-01

Contact for this trial

Changyi Quan

13388067990 345920147@qq.com

View on ClinicalTrials.gov More Renal Cell Carcinoma (RCC) trials