Immunotherapy after kidney cancer surgery: can a blood test predict who stays Cancer-Free?
NCT ID NCT07657325
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether the immunotherapy drug toripalimab can prevent kidney cancer from coming back in high-risk patients who have had their kidney removed. Researchers will also check if a blood test for minimal residual disease (MRD) can predict which patients benefit most. About 110 adults with high-risk renal cell carcinoma will receive toripalimab after surgery and be followed for cancer recurrence and survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (an immunotherapy drug)
- What this could lead to
- If successful, this could show that toripalimab helps prevent kidney cancer from returning after surgery, and that a blood test (MRD) can identify which patients need it most.
- What could go wrong
- This is a single-arm study with no placebo group, so results may be less definitive. The drug may cause immune-related side effects, and not all patients may benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 110 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Changyi Quan
RECRUITINGTianjin, Tianjin Municipality, 300211, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Engineered immune cells take on kidney cancer in first human test
- No clamps, no stitches: new robotic surgery aims to save more kidney function