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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

NCT05941325 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

  • Advanced or Unresectable Locally Advanced Bone and Soft Tissue Sarcoma

Interventions

DRUG

fruquintinib

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

DRUG

Envafolimab

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

Sponsors & Collaborators

  • Shanghai 6th People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05941325 on ClinicalTrials.gov