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NOT YET RECRUITING
NCT07904156
PHASE3

A Phase III Randomized Controlled Trial of Serplulimab Plus Fruquintinib as Adjuvant Therapy for High-Risk Non-Clear Cell Renal Cell Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2026-10-21

Completion Date

2032-12-30

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

DRUG

Serplulimab + Fruquintinib

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.