NCT06114173

Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma

Efficacy and Safety Study of Cardunolizumab in Soft Tissue Sarcoma After Failure of at Least Anthracycline-based Chemotherapy: a Single-arm Clinical Trial

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this type of study: clinical trial is to observe the efficacy and safety of cardunilizumab in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS), smooth muscle sarcoma, mucinous fibrosarcoma, and poorly differentiated/undifferentiated/polymorphic liposarcoma, etc.) . The main question\[s\] it aims to answer are: * Cardunilizumab is effective in soft tissue sarcomas after failure of at least first-line anthracycline-based chemotherapeutic agents, including undifferentiated sarcoma (UPS),smooth muscle sarcoma, mucinous fibrosarcoma, and poorly differentiated/undifferentiated/polymorphic liposarcoma) is effective . * Cardunilizumab has manageable adverse effects. Participants will be given Cardunolizumab 6mg/kg once every 2 weeks free

Detailed description

Some important factors for applying for this clinical trial: 1. sarcomas are dangerous, subtypically complex, and lack effective treatment. Soft Tissue Sarcoma treatment is looking for new drugs to improve patient prognosis. 2. PD-1 inhibitor monotherapy has shown initial efficacy in some soft tissue sarcoma subtypes. 3. Dual immunotherapy targeting PD-1 and CTLA-4 is more effective in the treatment of malignant tumors. 4. The "two-in-one" dual-antibody cardunculizumab, which is more potent and less toxic, has been approved for marketing by the Fast Track Review. 5. We hypothesize that the treatment of soft tissue sarcoma with cadunilizumab is safer and more effective than currently available immunotherapy options; however, this has not yet been reported.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
DRUG	Cardunilizumab	Cardunolizumab 6mg/kg was administered every 2 weeks, with the first evaluation at 8 weeks of treatment and subsequent evaluations every 12 weeks.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-06-30
• Completion: 2024-11-30
• First posted: 2023-11-02
• Last updated: 2023-11-02

Locations

1 site across 1 country: China