A Study of Durvalumab in Combination With Doxorubicin for Advanced Soft Tissue Sarcoma

Sponsor
Yonsei University
Study ID
NCT03802071
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 16, 2019
Status verified
Apr 2026
Primary completion
Aug 10, 2022
Completion
Aug 10, 2022

Study Design

Enrollment
44 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab+doxorubicin combination

Primary Outcome Measure

adverse event [ Time Frame: 3 weeks ]

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