Cadonilimab in the Treatment of Advanced Soft Tissue Sarcoma
- Conditions
- Soft Tissue Sarcoma
- Interventions
- Device: Cadonilimab
- Registration Number
- NCT05656144
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
The purpose of this study was to evaluate the efficacy and safety of Cadonilimab monotherapy in the treatment of patients with advanced soft tissue sarcoma who have received at least one chemotherapy (including anthracyclines) for advanced diseases (excluding alveolar soft part sarcoma).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 49
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- Written and signed informed consent.
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- Male or female, age≥ 18 and ≤ 70 years old on day of signing informed consent.
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- 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.
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- Patients who have failed at least one chemotherapy (including anthracyclines) in the last 6 months (excluding acinar soft tissue sarcoma).
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- Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
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- Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
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- 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).
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- Active autoimmune diseases;
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- History of transplantation;
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- Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cadonilimab Cadonilimab Cadonilimab monotherapy
- Primary Outcome Measures
Name Time Method Anti-tumor activity of Cadonilimab using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator up to 2 years The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) up to 2 years The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1.
AE From the subject signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
Duration of response (DoR) up to 2 years Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Progression-free survival (PFS) up to 2 years PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1 criteria) or death from any cause (whichever occurs first)
Overall survival (OS) up to 2 years Overall survival is defined as the time from the start of treatment with Cadonilimab until death due to any cause.
Time to recurrence (TTR) up to 2 years TTR is defined as the time to response base on RECIST v1.1