A Phase Ⅱ ,Open-label ,Single Institution Study to Investigate the Efficacy and Safety of Camrelizumab in Combination With Neoadjuvant Chemotherapy in the Treatment of Locally , Resectable Osteosarcoma

Sun Yat-sen University1 site in 1 country75 target enrollmentDecember 26, 2019

ConditionsOsteosarcoma

InterventionsCamrelizumab in Combination With Neoadjuvant Chemotherapy

DrugsCamrelizumab in Combination With Neoadjuvant Chemotherapy

Overview

Phase: Phase 2
Intervention: Camrelizumab in Combination With Neoadjuvant Chemotherapy
Conditions: Osteosarcoma
Sponsor: Sun Yat-sen University
Enrollment: 75
Locations: 1
Primary Endpoint: tumor cell necrosis rate (TCNR)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed 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.

Registry

clinicaltrials.gov

Start Date

December 26, 2019

End Date

September 16, 2023

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Jin Wang,MD

Director of bone and soft tissue

Sun Yat-sen University

Eligibility Criteria

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.