Soft Tissue Sarcoma
Conditions
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.
Interventions
DEVICECadonilimab
AK104, 6mg/kg, Q2W
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Time to recurrence (TTR) | up to 2 years | TTR is defined as the time to response base on RECIST v1.1 |
| 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. |
| 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. |
| 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. |
| 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) |
Outcome results
None listed