Phase II Study of Cadonilimab and Adriamycin for First-Line Treatment of Advanced Soft Tissue Sarcoma in Adults

What this Trial Is About

Researchers are evaluating cadonilimab combined with adriamycin in patients with advanced soft tissue sarcoma who have not received prior systemic therapy for this condition. This phase II, single-arm, multicenter trial aims to assess the objective response rate of this combination as a first-line treatment. The study focuses on patients with progressive disease not suitable for surgery and includes detailed monitoring to understand treatment effects and safety. The treatment starts with a run-in period where patients receive cadonilimab at 10 mgkg every three weeks. This is followed by a treatment period combining adriamycin at 25 mgm2 on days 1 to 3 every three weeks together with cadonilimab at the same dose and schedule. Afterward, patients enter a maintenance phase receiving cadonilimab alone every three weeks. Tumor imaging is performed every two cycles during the first 16 cycles and then every four cycles thereafter to assess treatment response. Participants undergo screening lasting up to 28 days before starting treatment. Throughout the study, they have scheduled visits for treatment administration, monitoring, and tumor imaging. Researchers assess various outcomes including objective response rate, disease control rate, duration of response, progression-free survival, overall survival, and adverse events. Safety is monitored from informed consent until 90 days after the last treatment. The study is expected to continue until March 2029, with patients needing to comply with scheduled visits and tests during this period.

A Trial of Cadonilimab With Adriamycin in Patients With Advanced Soft Tissue Sarcoma