Study of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of Osteosarcoma

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Recruiting
participants needed

75
sponsor

Sun Yat-sen University

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Updated on 19 February 2024

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methotrexate

measurable disease

monoclonal antibodies

psychotropic

ifosfamide

adriamycin

substance abuse

hepatitis c

camrelizumab

resectable osteosarcoma

Summary

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.

Description

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.

Details

Condition	Osteosarcoma, Osteosarcoma, Sarcoma, Sarcoma
Age	14years - 65years
Treatment	Camrelizumab in Combination With Neoadjuvant Chemotherapy
Clinical Study Identifier	NCT04294511
Sponsor	Sun Yat-sen University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age 14 to 65 year old
	Eastern Cooperative Oncology Group performance status 0-1
	Histopathologically diagnosed osteosarcomas (except for paraspesarcomas ), have been evaluated in patients have achieved normative resection with neoadjuvant chemotherapy
	Having measurable lesion according to RECIST 1.1
	Life expectancy >3 months
	Patients must have adequate organ function
	Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential must have a negative pregnancy test 72 hours prior to Day 1 of study
	Voluntary informed consent , joining the study with good compliance
Exclusion Criteria
	pregnant or lactating women
	Known history of hypersensitivity to any components of the camrelizumab formulation, or other antibody formulation
	Active central nervous system (CNS) metastases with clinical symptoms , including cerebral edema, steroid requirement, or progressive disease
	Patients with other malignant tumor within 5 years , except cured skin basal cell carcinoma, cervical carcinoma and Papillary carcinoma of thyroid
	Clinically significant cardiovascular diseases
	Patients have had prior treatment with PD-1/PD-L1 or CTLA-4 antagonists.Received any study drug within 4 weeks prior to the first study drug administration. Enroll in another clinical study, unless it is an observational (non-interventional) clinical study or an intervention follow-up study. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the allergy and nausea, vomiting are allowed. Inhaled or topical use of steroids and adrenocorticosteroid replacement in doses greater than 10mg/ day is permitted in the absence of active autoimmune disease.Patients who have received a live vaccine within 30 days prior to the first study drug administration.Major surgery or major trauma within 4 weeks of first study drug administration. Left ventricular ejection fraction (LVEF) is more than 60%
	(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 10 /ml or hepatitis C virus (HCV) RNA103 /ml or higher)
	Chronic hepatitis B virus carriers who HBV DNA2000 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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Study of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of Osteosarcoma