This is a single-arm, multicenter trial of cadonilimab (AK104) with adriamycin in patients with first-line advanced soft tissue sarcoma. the primary objective is to evaluate objective response rate of cadonilimab with adriamycin.
Patients who were pathologically confirmed soft tissue sarcoma (soft tissue sarcomas other than alveolar/embryonal rhabdomyosarcoma, clear cell sarcoma, extraosseous Ewing sarcoma, alveolar soft tissue sarcoma, well differentiated liposarcoma, extraosseous myxoid chondrosarcoma, etc.)
The patient was diagnosed as progressive and the investigators determined that the lesion was not suitable for surgical treatment
The patients had not received systemic therapy (including chemotherapy, targeted therapy and bioimmunotherapy) for advanced soft tissue sarcoma. More than 6 months have passed since the end of neoadjuvant/adjuvant therapy (including chemotherapy, targeted therapy, bioimmunotherapy, etc.), and the cumulative dose of adriamycin used in the past was ≤100 mg/m2
In patients with measurable disease, lesions are defined and monitored by RECIST v1.1
known allergy to recombinant humanized anti-PD-1 monoclonal antibody drugs and their components
Known allergy to recombinant humanized anti-CTLA-4 monoclonal antibody drug and its components
known allergy to any component of the cadonilimab formulation
Patients with cardiac disease class II or higher as determined by the New York Heart Association (NYHA) score
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Yunnan Cancer Hospital
Collaborator
The Affiliated Hospital Of Guizhou Medical University
Collaborator
First Affiliated Hospital of Guangxi Medical University
Collaborator
Second Xiangya Hospital of Central South University
Collaborator
Xiangya Hospital of Central South University
Collaborator