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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This study is a open-lable, , single center, phase II clinical study. Target population is patients with locally resectable osteosarcoma. Study objective is to compare the efficacy and safety of camrelizumab in combination with adriamycin, cisplatin, ifosfamide and methotrexate in study population in China. Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
In this study, eligible subject will be enrolled into study arm to accept study treatment. Treatment cycles of chemotherapy will be at most 9 cycles which will be decided by investigators. The percentage of the patient with tumor cell necrosis rate >90% determined by the Independent Review Committee (IRC) will be the primary outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | camrelizumab in combination with adriamycin, cisplatin, ifosfamide and methotrexate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab in Combination With Neoadjuvant Chemotherapy | Drug | camrelizumab in combination with adriamycin, cisplatin, ifosfamide and methotrexate |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor cell necrosis rate (TCNR) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2 years Overall Survival (OS) rate | The percentage of patients overall survival in 2 years | 24 months |
| 2 years Progression-free survival (PFS) rate | The percentage of patients Progression-free survival in 2 years |
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Inclusion Criteria:
Exclusion Criteria:
(7)Severe infection occurred within 4 weeks before the first first study drug administration (CTC AE > grade 2) (8)Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded. Stable dose of insulin for type 1 diabetes.
(9)History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or organ transplantation and bone marrow transplantation.
(10)Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
(11)History of active pulmonary tuberculosis infection, or with a history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or with a history of active pulmonary tuberculosis infection prior to 1 year but without formal treatment.
(12)Active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA ≥10⁴ /ml or hepatitis C virus (HCV) RNA≥103 /ml or higher); Chronic hepatitis B virus carriers who HBV DNA<2000 IU/ml(<104/ml), must receive anti-viral treatment throughout the study.
(13)Known history of psychotropic substance abuse, alcohol abuse and drug abuse.
(14)The investigators did not think the participants were suitable for inclusion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin WANG, MD | Contact | 020-87343910 | wangjinr@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Sun-Yat Sen University (CCSYSU) | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D020360 | Neoadjuvant Therapy |
| D000082082 | Immune Checkpoint Inhibitors |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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| 24 months |
| Adverse Events (AEs) | All adverse event/Serious adverse event that occurred during the study period according to CTCAE | 24 months |
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |