RecruitingPhase 2NCT05831891

Fruquintinib and SeRplulimab: Opening New Frontiers in Treating Non-clear Cell Renal Cell Carcinoma

A Single-arm, Multicenter, Prospective Clinical Study of Efficacy and Safety of Fruquintinib Combined With Serplulimab in First-line Treatment of Non-clear Renal Cell Carcinoma


Sponsor

RenJi Hospital

Enrollment

39 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is design to prospectively investigate the safety and efficacy of Fruquintinib combined with Serplulimab in first-line treatment of non-clear renal cell carcinoma. Fruquintinib, a vascular endothelial growth factor receptor inhibitor, is an anticancer drug independently developed in China to treat refractory metastatic colorectal cancer (mCRC). This is a Single-arm, multicenter, prospective phase 2 clinical study.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — fruquintinib (a targeted therapy) and serplulimab (an immunotherapy) — as a first-line treatment for people with a rare, non-clear cell type of kidney cancer that has spread or cannot be removed with surgery. The aim is to see whether this drug combination can shrink tumors and extend survival. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with metastatic or unresectable non-clear cell kidney cancer - You have not yet received any systemic treatment (no prior chemo, targeted therapy, or immunotherapy) - Your general health is good (ECOG score 0–1) - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have had prior systemic cancer treatment - You have uncontrolled hepatitis B or C - You are pregnant or breastfeeding - You have had serious allergic reactions to the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFruquintinib combined with Serplulimab

Fruquintinib 5mg, qd, 2w on/1w off and Serplulimab 4.5mg/kg, IV drip, d1, q3w


Locations(1)

Renji Hospital

Shanghai, Shanghai Municipality, China

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NCT05831891


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