NCT06367075

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

The Efficacy and Safety of Cadonilimab(AK104) With Adriamycin for First-line Treatment of Advanced Soft Tissue Sarcoma: a Multicenter, Single-arm, Phase II Clinical Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study, the screening period does not exceed 28 days, and subjects who are qualified after completion of the screening examination and evaluation entered the treatment period and undergo study treatment and visits as specified in the protocol. In particular, tumor imaging assessments are performed every 2 cycles during the first 16 cycles; thereafter, tumor imaging assessments are performed every 4 cycles.

Conditions

• Advanced Soft-tissue Sarcoma

Interventions

Type	Name	Description
DRUG	Cadonilimab	injectable solution
DRUG	Adriamycin	injectable solution

Timeline

• Start date: 2024-10-09
• Primary completion: 2027-03-31
• Completion: 2029-03-31
• First posted: 2024-04-16
• Last updated: 2025-07-18

Locations

1 site across 1 country: China