Phase II Clinical Trial Scheme of Ganoderma Lucidum Spore Powder for Postoperative Chemotherapy of Osteosarcoma
Osteosarcoma
About this trial
This is an interventional treatment trial for Osteosarcoma focused on measuring Ganoderma lucidum, osteosarcoma
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form
Clinical diagnosis of osteosarcoma
Must be able to swallow tablets
after surgical resection
Exclusion Criteria:
- Symptomatic central nervous system metastases and/or carcinomatous meningitis Known HIV or active hepatitis B/C infection
Active infection requiring systemic treatment
Clinically significant cardiac arrhythmias
Class III or IV Congestive Heart Failure as defined by the New York Heart
Association functional classification system < 6 months prior to screening
A pregnant or nursing female, or women of child-bearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
Any condition for which participation would not be in the best interest of the participant
Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
Patients participating in another clinical investigation at the time of signature of the informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Sham Comparator
Placebo Comparator
Experimental
sham group
NC group
experimental group
Treated with conventional chemotherapy drugs
Treated with conventional chemotherapy drugs and Placebo
Treated with conventional chemotherapy drugs and Ganoderma lucidum