Actively Recruiting
A Prospective, Multicenter, Non-randomized Controlled Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Patients With Osteosarcoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-04-17
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the tumor necrosis rate in patients with osteosarcoma treated with a neoadjuvant regimen combining surufatinib and chemotherapy. This phase II, prospective, multicenter, controlled study aims to assess the efficacy and safety of surufatinib, a drug that inhibits colony-stimulating factor 1 receptor, which may have tumor-inhibiting effects on sarcoma. The study includes 160 participants divided into two groups to compare surufatinib plus chemotherapy versus chemotherapy alone. Participants in the study receive treatment cycles lasting 30 days. One group receives surufatinib combined with chemotherapy, while the other receives chemotherapy only. The surufatinib dose varies by age and body surface area, with specific chemotherapy drugs administered in a set schedule over the cycle. After two cycles of neoadjuvant therapy, the tumor necrosis rate is evaluated to measure treatment impact. During the study, participants undergo evaluations including tumor assessments, blood tests, and monitoring for adverse events. The primary outcome is the tumor cell necrosis rate after 12 months. Secondary outcomes include progression-free survival at one year and safety assessments over 24 months according to standard criteria. Participants are monitored for organ function, tumor response, and treatment side effects throughout the treatment and follow-up periods.
CONDITIONS
Brief Title
A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 2 to 70 years old (inclusive), both male and female
- Histologically or cytologically confirmed diagnosis of primary bone tumor
- At least one measurable lesion according to RECIST 1.1 criteria
- No prior treatment including chemotherapy, targeted therapy, immune therapy, or other drugs
- Normal major organ and bone marrow function
- ECOG performance status of 0 or 1 (PS 0-2 for amputees)
- Expected survival of at least 12 weeks
- Blood test results meeting specified thresholds for neutrophils, platelets, hemoglobin, liver and renal function
- Fertile patients agree to use effective contraception during the study and for 6 months after last dose
- Informed consent signed voluntarily
You will not qualify if you...
- Prior treatment with chemotherapy drugs, surufatinib, or other antiangiogenic agents
- Systemic anti-tumor therapy within 4 weeks before enrollment
- Surgery or invasive treatment within 4 weeks prior to enrollment
- Abnormal blood clotting parameters (INR > 1.5 or APTT > 1.5 times normal)
- Clinically significant electrolyte abnormalities
- Uncontrolled hypertension (systolic 6140 mmHg or diastolic 690 mmHg)
- Poor blood glucose control (FBG > 10 mmol/L)
- Diseases affecting drug absorption or inability to take surufatinib orally
- Active gastrointestinal diseases with risk of bleeding or perforation
- Significant bleeding events or thromboembolic events within defined timeframes
- Clinically significant cardiovascular diseases or heart failure NYHA grade > 2
- Other malignancies within past 5 years except certain skin or cervical cancers
- Active or uncontrolled severe infections including HIV, hepatitis B or C
- Central nervous system metastases
- Persistent toxicity from prior antitumor therapy above grade 2 except alopecia or lymphocytopenia
- Pregnancy or breastfeeding
- Blood transfusion or hematopoietic factor use within 14 days prior to enrollment
- Any medical condition or abnormality judged unsuitable by investigators
- Urinary protein 2+, or 24-hour urinary protein > 1.0g
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 cycles of 30 days each
Participants receive surufatinib combined with chemotherapy or chemotherapy alone as neoadjuvant treatment for osteosarcoma.
2 treatment cycles with visits according to chemotherapy schedule
Duration - Up to 24 months
Participants are monitored for tumor necrosis rate, progression-free survival, and safety for up to 24 months after treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
B
Binghao Li, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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