Could an immunotherapy drug keep kidney cancer from returning after surgery?
NCT ID NCT06584435
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing whether toripalimab, an immunotherapy drug, can prevent high-risk kidney cancer from coming back after surgery to remove the kidney. About 100 participants will receive the drug every three weeks for up to a year. Researchers will track how long they stay cancer-free and monitor side effects.
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 anti-PD-1 antibody)
- What this could lead to
- If it works, this could offer a new option to delay or prevent kidney cancer from coming back after surgery.
- What could go wrong
- This is a small, early-phase study with no comparison group, so results may not be definitive. Side effects from immunotherapy can be serious.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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100 people
The number who actually took part.
- Started
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Oct 2022
- Expected to finish
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Nov 2027
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.
- 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. INCLUSION CRITERIA Participants must meet ALL of the following criteria to be eligible for study enrollment: 1.1 Informed Consent Capable of giving signed informed consent; Willing to comply with all study procedures; Signed and dated written informed consent obtained prior to any study-specific procedures. 1.2 Age and Sex Age ≥18 years at time of consent; Male and female participants eligible. 1.3 Disease Characteristics Histologically confirmed renal cell carcinoma with clear cell component; Must have undergone nephrectomy with complete resection; No evidence of residual tumor confirmed by imaging; Must meet at least ONE of the following high-risk criteria: pT2,with Fuhrman Grade IV or sarcomatoid,N0,M0;pT3/4,N0M0 (any grade);Any T classification with N1,M0;Post nephrectomy(total/partial) plus complete resection of metastasis, M1 NED. 1.4 Brain Metastasis No suspected or confirmed active brain metastases. 1.5 Performance Status Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 1.6 Organ Function (within 14 days prior to enrollment, without transfusion or growth factor support) Hematopoietic function: Absolute neutrophil count ≥1,500/mm³; Platelet count ≥100,000/mm³; Hemoglobin ≥9.0 g/dL (5.6 mmol/L) Hepatic function: Total bilirubin ≤1.5 × ULN; AST and ALT ≤1.5 × ULN Renal function: Serum creatinine ≤1.5 mg/dL; OR creatinine clearance ≥60 mL/min (Cockcroft-Gault formula) 1.7 Contraception Females of childbearing potential must use medically approved contraception during treatment and for 3 months after last dose; Negative serum or urine pregnancy test within 7 days prior to randomization for women of childbearing potential; Non-lactating females; Males with female partners of childbearing potential must use effective contraception during treatment and for 3 months after last dose 1.8 Compliance Voluntarily agrees to participate by signing informed consent; Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures 2. EXCLUSION CRITERIA Participants meeting ANY of the following criteria will be excluded from study participation: 2.1 Prior Therapy Previous radiotherapy, chemotherapy, targeted therapy, long-term or high-dose hormone therapy, or any immune checkpoint inhibitor treatment. 2.2 Concurrent Malignancy History of or current concurrent malignancy (except adequately treated basal cell carcinoma of skin, carcinoma in situ of cervix, etc.). 2.3 Allergy and Prior Immunotherapy Previous treatment with other PD-1/PD-L1 inhibitors; Known hypersensitivity to macromolecular protein preparations or any PD-1 inhibitor components. 2.4 Autoimmune Disease Active autoimmune disease or history of autoimmune disease; Exceptions:Controlled type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases not requiring systemic treatment (vitiligo, psoriasis), or childhood asthma in complete remission without intervention in adulthood. 2.5 Immunosuppressive Therapy Current use of immunosuppressants (e.g., systemic corticosteroids \>10 mg/day prednisone equivalent) for immunosuppressive purposes, continued within 2 weeks prior to enrollment. 2.6 Cardiovascular Disease Poorly controlled cardiac clinical symptoms or diseases, including: NYHA Class II or higher heart failure; Unstable angina pectoris; Myocardial infarction within 1 year; Clinically significant arrhythmias requiring treatment 2.7 Coagulation Function Abnormal coagulation function with bleeding tendency; Current thrombolytic or anticoagulant therapy; 2.8 Gastrointestinal Disease Current active gastrointestinal diseases including: Esophageal varices; Active ulcers; Inflammatory bowel disease; Risk of perforation or bleeding; 2.9 Hemorrhage and Thrombosis Events History of or current severe hemorrhage, hemoptysis, or thrombotic events within 12 months. 2.10 Infection Active infection requiring systemic therapy; Unexplained fever \>38.5°C during screening or before first dose; Congenital or acquired immunodeficiency, including HIV infection or active hepatitis 2.11 Other Medical Conditions History of severe pulmonary fibrosis, interstitial pneumonia, radiation pneumonia; Live vaccination within 4 weeks prior to study treatment; History of psychotropic drug abuse, alcoholism, or drug addiction 2.12 Administrative Reasons Participation in another clinical study or within 1 month after completion of previous clinical study; Any condition that, in the investigator's judgment, may lead to early study termination affecting participant safety or data quality 3. WITHDRAWAL CRITERIA Participants will be withdrawn from study treatment if ANY of the following occurs: 3.1 Participant Request Participant or legal representative requests withdrawal 3.2 Disease Progression Confirmed disease progression 3.3 Intolerable Toxicity Occurrence of intolerable toxicities 3.4 Investigator Judgment Investigator determines continued participation may harm the participant 3.5 Protocol Violations Pregnancy Loss to follow-up Major protocol violation 3.6 Treatment Delay Any cause leading to treatment delay \>2 weeks.
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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.
Contacts and locations
Locations
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Changyi Quan
Tianjin, Tianjin Municipality, 300211, China