SerF-ADJ
A Randomized, Controlled, Multicenter Phase III Study of Serplulimab Plus Fruquintinib Versus Observation as Adjuvant Treatment for Patients With High-Risk Non-Clear Cell Renal Cell Carcinoma
Sponsor study identifier
Secondary identifiers
OTHER · Sun Yat-sen University cancer center
interventional
108
0 countries
N/A
Study Start
October 21, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
People with non-clear cell renal cell carcinoma may remain at high risk of cancer recurrence even after surgery has removed all visible disease. This study will test whether treatment after surgery with serplulimab plus fruquintinib improves outcomes compared with observation alone. This is a multicenter, randomized, open-label Phase III study. Approximately 108 adults will be assigned in a 1:1 ratio to receive the drug combination or observation. Participants in both groups will undergo scheduled follow-up. The main measure is the proportion of participants who remain free of recurrence two years after randomization. The study will also assess recurrence-free survival over time, overall survival, safety, and exploratory biomarkers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 19, 2026
Actual (reported)October 21, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 29, 2026
Actual (reported)December 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
2-Year Recurrence-Free Survival (RFS) Rate
The Kaplan-Meier estimated percentage of randomized participants who are alive without documented local, regional, or distant recurrence 24 months after randomization.
2-year
Overall Survival (OS)
2-year
Incidence and Severity of Adverse Events
From the date of informed consent until 90 days after the last dose of serplulimab or 30 days after the last dose of fruquintinib, whichever is later, or until the initiation of new anticancer therapy, whichever occurs first; assessed up to 27 months
Clinically Significant Laboratory Abnormalities
From enrollment to the end of treatment, assessed up to 27 months.
Participants will start adjuvant treatment within 12 weeks after surgery. Serplulimab 300 mg will be administered by intravenous infusion every 3 weeks for up to 17 cycles. Fruquintinib 5 mg will be taken orally once daily for 14 days, followed by 7 days off, for a total of 12 weeks.
Participants will receive no adjuvant study treatment after surgery. They will undergo scheduled clinical and imaging assessments every 12 weeks to monitor for disease recurrence and survival.
Participants will start adjuvant treatment within 12 weeks after surgery. Serplulimab 300 mg will be administered by intravenous infusion every 3 weeks for up to 17 cycles. Fruquintinib 5 mg will be taken orally once daily for 14 days, followed by 7 days off, for a total of 12 weeks.
Linked from the registry description. Each source intervention is retained as reported.
In: Serplulimab + Fruquintinib
In: Serplulimab + Fruquintinib
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Serplulimab + Fruquintinib
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFirst Submitted
October 19, 2026
First Posted
October 29, 2026
Study Start
October 21, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Primary Completion
December 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Individual participant data (IPD) will not be publicly shared due to patient privacy and confidentiality considerations, as well as ethical and regulatory restrictions. The study data will be securely maintained by the investigators and used in accordance with the approved study protocol and applicable regulations.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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