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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:
Some important factors for applying for this clinical trial:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| drug-dosing group | Experimental | Cardunolizumab 6mg/kg was administered every 2 weeks, with the first evaluation at 8 weeks of treatment and subsequent evaluations every 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardunilizumab | Drug | Cardunolizumab 6mg/kg was administered every 2 weeks, with the first evaluation at 8 weeks of treatment and subsequent evaluations every 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate,ORR | Tumor volume reduction of up to 30%(According to RECIST 1.1 efficacy evaluation criteria) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | according to criteria CTCAE 5.0,the ratio of AE and SAE which were defined by the common terminology criteria for adverse events,CTCAE. | 24 months |
| Incidence of immune-related adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| PD-L1 immunohistochemical assay values | Immunohistochemical testing values for all patients were completed by our pathology department | 24MONTHS |
Inclusion Criteria:
agree to sign the informed consent form.
18 years ≤ age < 75 years.
Pathologic subtypes include undifferentiated sarcoma (UPS), smooth muscle sarcoma, mucinous fibrosarcoma, poorly differentiated/ dedifferentiated/ pleomorphic Liposarcoma; diagnosis confirmed by pathology at a tertiary care hospital.
soft tissue sarcoma evaluated as metastatic or inoperable.
previous systemic therapy including at least anthracycline-based chemotherapeutic agents.
at least one measurable lesion (CT or MRI); Tissue specimen which can be safely obtained by vacutainer before and during treatment.
ECOG physical status score of 0-1.
an expected survival time of >12 weeks.
Normal major organ function, i.e., the following criteria are met:
a) Hematology: i. Absolute neutrophil count ANC ≥ 1.5 × 109/L (1,500/mm3). ii. Platelet count ≥ 80 × 109/L (80,000/mm3 ). iii.Hemoglobin ≥ 90 g/L. b) Liver: i. Serum total bilirubin (TBil) ≤ 1.5 × ULN. ii. AST and ALT ≤ 2.5 × ULN. iii. serum albumin (ALB) ≥ 28 g/L. iv. serum bilirubin (ALB) ≤ 1.5 × ULN. c) Coagulation function: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN.
d) Cardiac function: i. Left ventricular ejection fraction (LVEF) ≥ 50%.
Female subjects of childbearing potential must undergo a urine or serum pregnancy test within 3 days prior to the first dose (if the urine pregnancy test is not confirmed).
The subject is willing and able to comply with the schedule of visits, treatment regimens, laboratory tests, and other requirements of the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| bin Li, doctor | Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28391775 | Result | Savina M, Le Cesne A, Blay JY, Ray-Coquard I, Mir O, Toulmonde M, Cousin S, Terrier P, Ranchere-Vince D, Meeus P, Stoeckle E, Honore C, Sargos P, Sunyach MP, Le Pechoux C, Giraud A, Bellera C, Le Loarer F, Italiano A. Patterns of care and outcomes of patients with METAstatic soft tissue SARComa in a real-life setting: the METASARC observational study. BMC Med. 2017 Apr 10;15(1):78. doi: 10.1186/s12916-017-0831-7. | |
| 28988646 |
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we will share the some dates to the website:http://www.medresman.org.cn/login.aspx or publication of results of clinical trials in the form of papers
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
Adverse effects due to the use of immunotherapy
| 24 months |
| overall survival,OS | Time from initiation of immunotherapy to death or time lost to visit. | 24 months |
| progression-free survival,PFS | Time from initiation of immunotherapy to disease progression or death from other causes. | 24 months |
| Result |
| Tawbi HA, Burgess M, Bolejack V, Van Tine BA, Schuetze SM, Hu J, D'Angelo S, Attia S, Riedel RF, Priebat DA, Movva S, Davis LE, Okuno SH, Reed DR, Crowley J, Butterfield LH, Salazar R, Rodriguez-Canales J, Lazar AJ, Wistuba II, Baker LH, Maki RG, Reinke D, Patel S. Pembrolizumab in advanced soft-tissue sarcoma and bone sarcoma (SARC028): a multicentre, two-cohort, single-arm, open-label, phase 2 trial. Lancet Oncol. 2017 Nov;18(11):1493-1501. doi: 10.1016/S1470-2045(17)30624-1. Epub 2017 Oct 4. |