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A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma
Sponsor: Yonsei University
Summary
The yearly incidence of soft-tissue sarcomas (STS) in the USA is roughly 11,280 cases, and metastatic STS have a median overall survival of about 12 months. Sarcomas of the soft tissue are a heterogeneous group of malignant tumors of mesenchymal origin that originate in connective tissue. Local control with wide surgical resection with or without adjuvant radiation has a success rate of close to 90%. However, approximately 40% to 50% of patients with a large (\>5 cm), deep, high-grade soft-tissue sarcoma eventually develop distant metastases, primarily in the lung. Therefore, overall survival of metastatic STS remained still poor, less than 1 year. Therefore, current clinical trials with various targeted agents are ongoing add on the doxorubicin monotherapy. Investigator planned to conduct the phase I/II trial of durvalumab in combination with standard chemotherapy, doxorubicin for metastatic/recurred sofe tissue sarcoma.
Official title: A Phase I/II Study of Durvalumab in Combination With Standard Chemotherapy Doxorubicin for Advanced Soft Tissue Sarcoma
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2019-09-16
Completion Date
2022-08-10
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
Durvalumab+doxorubicin cobination
Durvalumab 1500mg IV Doxorubicin 75mg/m2 IV D1 Q3weeks (up to 8cycles)
Locations (1)
Severance Hospital, Yonsei University Health System
Seoul, South Korea