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COMPLETED
NCT03802071
PHASE1/PHASE2

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

Sponsor: Yonsei University

View on ClinicalTrials.gov

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

DRUG

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