INTERNATIONAL: Adriamycin and Ifosfamide Combined With Sintilimab for Advanced SoftTissue Sarcoma
Trial ID: NCT04589754
Phase: Phase 2
Status: Recruiting
Last Update Posted: January 2024
Eligibility: Patients aged 14 to 70 with advanced or unresectable soft tissue sarcoma, including synovial sarcoma, who have failed or cannot tolerate standard treatment and have at least one measurable lesion. Patients must have an ECOG performance status of 0-1 and adequate organ function.
Overview: This Phase 2 randomized trial compares adriamycin and ifosfamide chemotherapy combined with sintilimab, a PD-1 checkpoint inhibitor, against chemotherapy alone as second-line treatment for patients with advanced or unresectable soft tissue sarcoma. The study aims to determine whether adding sintilimab to standard chemotherapy can improve outcomes for patients whose disease has progressed or who cannot tolerate first-line therapy.
Preliminary Effectiveness: The primary goal is overall response rate at 24 months. Secondary goals include progression-free survival, disease-free survival, and overall survival. No results have been posted to ClinicalTrials.gov at this time.

Study Contact: Xing Zhang

Treatment Centers: China