RecruitingPhase 2NCT05941325

A Single-arm, Open-label, Single-center Prospective Study of Fruquintinib Combined With Envafolimab in the Treatment of Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma

Shanghai Sixth People's Hospital


Sponsor

Shanghai 6th People's Hospital

Enrollment

20 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Many osteosarcomas are cured with a variety of combined chemotherapy and surgery, but a significant number will still relapse.VEGF promotes an immunosuppressive microenvironment and contributes to immune checkpoint inhibitor resistance in cancer.We aimed to explore the efficacy and safety of fruquintinib combined immunotherapy for bone and soft tissue sarcoma.


Eligibility

Min Age: 12 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — fruquintinib (a blood vessel growth blocker) and envafolimab (an immunotherapy checkpoint inhibitor) — for people with advanced or locally advanced bone and soft tissue sarcomas that have stopped responding to standard treatments. **You may be eligible if...** - You are between 12 and 70 years old - You have advanced or locally unresectable bone or soft tissue sarcoma confirmed by biopsy - Your cancer has progressed after at least one line of standard treatment - You are in good enough health to participate (adequate organ function) **You may NOT be eligible if...** - You have not received any prior treatment for your sarcoma - You have certain subtypes of sarcoma that are excluded (such as gastrointestinal stromal tumors or Kaposi's sarcoma) - You have serious active infections, heart conditions, or organ dysfunction - You have received prior treatment with these specific drugs or similar agents 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

VEGF receptor tyrosine-kinase inhibitor:fruquintinib(4mg), Oral,qd, d1-d14, Q3w,Until disease progression or intolerable toxicity occurs.

DRUGEnvafolimab

anti-PD-1 immune checkpoint inhibitor:Envafolimab(400mg), subcutaneous injection, d1, Q3w,Until disease progression or intolerable toxicity occurs.


Locations(1)

Shanghai No.6 People Hospital

Shanghai, Shanghai Municipality, China

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NCT05941325