New drug cocktail aims to prevent kidney cancer recurrence in High-Risk patients
NCT ID NCT07488533
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining two drugs—serplulimab and fruquintinib—can prevent kidney cancer from returning after surgery in people with a rare, aggressive type called non-clear cell renal cell carcinoma. About 40 adults at high risk of recurrence will receive both drugs for up to 12 months. The goal is to see how long they stay cancer-free and whether this approach can become a new standard treatment.
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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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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Dec 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.
- Ages
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18 to 75 years
- 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.
Inclusion Criteria: * Age between 18 and 75 years, inclusive. * Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes. * Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology. * High-risk features defined as one or more of the following: pT3 or higher, regional lymph node involvement (N1), sarcomatoid differentiation, tumor necrosis, Fuhrman/ISUP nuclear grade ≥3, or positive surgical margin. * ECOG performance status of 0 or 1. * Adequate organ function: neutrophils ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; creatinine clearance ≥50 mL/min; INR ≤1.5. * No prior adjuvant or neoadjuvant systemic anti-tumor therapy. * Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component. * Evidence of distant metastasis (M1) at baseline. * History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents. * Uncontrolled hypertension (systolic \>150 mmHg or diastolic \>100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.
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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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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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