Using residual cancer cell tests to predict toripalimab results in kidney cancer after surgery
Studies whether leftover cancer tests predict toripalimab outcomes in kidney cancer after surgery.
Plain-language title generated from the registry record
Registry title: Study on MRD Prediction of Efficacy of Toripalimab in the Treatment of High-risk Recurrent Renal Carcinoma
Key facts
- Where
- Tianjin, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with high-risk renal cell carcinoma who had kidney surgery and will get Toripalimab afterwards.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Renal cell carcinoma confirmed under the microscope. High risk means pT4, N0, M0, or any pT stage with positive lymph nodes and M0. Also M1 NED: a kidney tumor plus isolated soft tissue spread that was fully removed at surgery.
- Earlier treatment
- No earlier systemic treatment for advanced disease, except kidney surgery. Radical nephrectomy with clear surgical margins (and full removal of spread in M1 NED).
Main reasons for not taking part
- Tumor not shown to be gone on CT or MRI
- Suspected brain metastases
- ECOG performance status other than 0 or 1
- Breastfeeding, or a positive pregnancy test
- Blood, kidney or liver test results outside the limits set in the record
Read by machine on 12 November 2026.
Where in China
- Changyi QuanTianjin, ChinaContact: Changyi Quan, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tianjin Medical University Second Hospital
- Trial code
- NCT07657325
- Record updated
- 18 June 2026
- Original description
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.Read full original descriptionShow less
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.
There must be a histological diagnosis of renal cell carcinoma, with or without sarcomatoid features of clear cell components; On the day of signing the informed consent form, both males and females must be at least 18 years old; The participants provide written informed consent for the trial before enrollment; Have high risk or M1 NED renal cell carcinoma as defined by the following pathological tumor-node-metastasis and Fuhrman grading status; High risk RCC; pT4, Any Gr. N0, M0; pT Any stage, Any Gr., N+, M0; 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); No previous systemic treatment for advanced RCC (except nephrectomy or pyelectomy) has been performed; Radical nephrectomy (and complete resection of metastatic lesions in M1 NED participants) was performed with a negative surgical margin; It must be evaluated by the investigator as tumor-free and verified by imaging such as CT or MRI. No suspicious brain metastases; Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1; 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; 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.