Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Dec 9, 2022

Keywords

ClinConnect Summary

After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period (≤28 days) to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be treated with Cadonilimab monotherapy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written and signed informed consent.
• • 2. Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent.
• • 3. Pathologically confirmed unresectable or metastatic soft tissue sarcoma, mainly including Undifferentiated pleomorphic sarcoma/malignant fiber histiocytoma, Alveolar soft part sarcoma, dedifferentiated liposarcoma, fibrosarcoma, Leiomyosarcoma, Anigosarcoma, Synovial sarcoma.
• • 4. Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma).
• Exclusion Criteria:
• • 1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
• • 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
• • 3. Prior exposure to any experimental antitumor vaccines, or any agent targeting T-cell costimulation or immune checkpoint pathways (eg, anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-CD137 or anti-OX40 antibody, etc).
• • 4. Active autoimmune diseases;
• • 5. History of transplantation;
• • 6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).