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New treatment option for Osteosarcoma
Official title A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma
ClinicalTrials.gov ID: NCT05926492
What this study is testing
What is Surufatinib plus chemotherapy?
Surufatinib plus chemotherapy is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for osteosarcoma.
Also referred to as Arm A.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 70
You may be able to join if
- Have fully understood the study and voluntarily signed the informed consent;
- Age from 2 to 70 years old (inclusive), both male and female;
- histologically or cytologically confirmed diagnosis of primary bone tumor
- having at least one measurable lesion (RECIST 1.1);
- The patient has not been treated before (including any chemotherapy, targeting, immune and other drugs);
You likely can't join if
- Patients who have previously received chemotherapy drugs, surufatinib, or other antiangiogenic agents;
- Received approved or under development systematic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy...
- Received any surgery or invasive treatment or operation (except intravenous catheterization, puncture drainage, etc.) within 4 weeks before...
- International Standardized Ratio (INR)\> 1.5 or partially activated prothrombin time (APTT) \> 1.5×ULN;
- The investigator identified clinically significant electrolyte abnormalities;
- The patient currently has hypertension that cannot be controlled by drugs, as follows: systolic blood pressure ≥140 mmHg and/or diastolic blood...
See the full eligibility criteria
- Have fully understood the study and voluntarily signed the informed consent;
- Age from 2 to 70 years old (inclusive), both male and female;
- histologically or cytologically confirmed diagnosis of primary bone tumor
- having at least one measurable lesion (RECIST 1.1);
- The patient has not been treated before (including any chemotherapy, targeting, immune and other drugs);
- The functions of major organs and bone marrow are basically normal;
- ECOG performance status 0 or 1 (PS 0-2 points for amputees);
- Expected survival ≥12 weeks;
- Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value ≥1.5×109/L, platelets ≥100×109/L, hemoglobin concentration ≥9g/dL); 2) Liver function test (aspartate aminotransferase and glutamic...
- Fertile male or female patients voluntarily used effective contraceptive methods, such as double barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and...
- Patients who have previously received chemotherapy drugs, surufatinib, or other antiangiogenic agents;
- Received approved or under development systematic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, etc.;
- Received any surgery or invasive treatment or operation (except intravenous catheterization, puncture drainage, etc.) within 4 weeks before enrollment;
- International Standardized Ratio (INR)\> 1.5 or partially activated prothrombin time (APTT) \> 1.5×ULN;
- The investigator identified clinically significant electrolyte abnormalities;
- The patient currently has hypertension that cannot be controlled by drugs, as follows: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Unsatisfactory blood glucose control (FBG \> 10 mmol/L);
- The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take surufatinib orally;
- The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumors, or other conditions determined by researchers that may cause...
- Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding \>30 mL within 3 months , hematemesis, stool, stool blood), hemoptysis ( \> 5 mL of fresh blood within 4...
- Clinically significant cardiovascular disease, including but not limited to the following: acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to...
- Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
- Active or uncontrolled severe infection; 1) Known human immunodeficiency virus (HIV) infection; 2) Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA...
- The patient has current central nervous system (CNS) metastases or previous brain metastases;
- Patients with persistent toxicity due to any previous antitumor therapy that has not returned to ≤ grade 2, but with alopecia or lymphocytopenia of any grade are admitted to this study;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical...
- Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein quantification \>1.0g.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.