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Recruiting Phase 2 NCT05926700

Efficacy and Safety of Cadonilimab Plus Anlotinib in Advanced STS That Failed the Previous First-line Standard Treatment

Trial Parameters

Condition Soft Tissue Sarcoma
Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 27
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2024-02-28
Completion 2026-04-01
Interventions
Candonilimab

Brief Summary

Objective to evaluate the efficacy and safety of candonilimab combined with anlotinib in the treatment of progressive or metastatic soft tissue sarcoma that failed previous first-line standard therapy.

Eligibility Criteria

Inclusion Criteria: 1. Male or female, aged 18 to 70 years (including 18 and 70). 2. Voluntarily sign written informed consent. 3. Advanced or unresectable soft tissue sarcomas confirmed by pathology mainly include liposarcoma, leiomyosarcoma, synovial sarcoma, undifferentiated pleomorphic sarcoma / malignant fibrous histiocytoma, fibrosarcoma, pleomorphic rhabdomyosarcoma, acinar soft tissue sarcoma, clear cell sarcoma, angiosarcoma, epithelioid sarcoma, malignant peripheral nerve sheath tumor, undifferentiated sarcoma, sarcoma after radiotherapy, etc. 4. Patients who have used at least one chemotherapy regimen (including anthracyclines) in the past (except for acinar soft tissue sarcoma and clear cell sarcoma) and are evaluated as disease progression according to the efficacy evaluation criteria of solid tumors within 6 months. 5. According to RECIST 1.1, there was at least one measurable tumor lesion. 6. ECoG score 0 or 1. 7. The expected survival was ≥ 3 months. 8. The main organs

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