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

  • STATUS
    Recruiting
  • End date
    Sep 16, 2023
  • participants needed
    75
  • sponsor
    Sun Yat-sen University
Updated on 28 February 2022
methotrexate
monoclonal antibodies
measurable disease
cancer chemotherapy
ifosfamide
adriamycin
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
Treatment Camrelizumab in Combination With Neoadjuvant Chemotherapy
Clinical Study IdentifierNCT04294511
SponsorSun Yat-sen University
Last Modified on28 February 2022

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 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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