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Clinical Trials in China / NCT05106777
Active, not recruiting Phase 2

Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma

NCT05106777 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2021-12-10
Last updated
2026-06-11

Condition(s) studied

Sarcoma

Investigational drug(s) / intervention(s)

Surufatinib

Surufatinib: Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle.

Study summary

The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy.

Eligibility

Sex
ALL
Min age
14 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Fully understand the study and voluntarily sign the informed consent form; 2. Male or female, age14-70 years,the body surface area of patients under 18 years old is ≥1.5m2; 3. Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic); 4. The patient had previously failed standard chemotherapy,Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if 6 months or more have passed since completion of therapy. 5. Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2). 6. Life expectancy \> 12 weeks. 7. Have measurable disease based on RECIST 1.1. Exclusion Criteria: 1. Prior treatment with Surufatinib; 2. Systemic anti-tumor therapy, including cytotoxic therapy, signal transduction inhibitors, and immunotherapy, is planned for the first 4 weeks prior to enrollment or during the study. Radiation radiotherapy (EF-RT) was performed within 4 weeks prior to enrollment. 3. Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.) 4. With pleural effusion or ascites, cause respiratory syndrome. (\> CTC AE grade 2 dyspnea \[grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily life\]) 5. had central nervous system metastasis; 6. With severe and failed to controlled diseases. (including:1)Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg, despite optimal drug treatment).2)Arrhythmias with grade II and above myocardial ischemia or myocardial infarction, poor control (including corrected QT interval(QTc) men ≥ 450 ms, women ≥ 470 ms) and ≥ 2 congestive heart failure (New York Heart Association ( NYHA) rating).3)Poor control of diabetes (fasting blood glucose \> 10mmol / L).4)Active or uncontrolled serious infection (≥ Common Terminology Criteria for Adverse Event(CTC AE) grade 2 infection);5)Patients with active hepatitis B or hepatitis C (hepatitis B: HBsAg-positive and hepatitis B virus(HBV) DNA ≥ 500 IU/mL; hepatitis C: hepatitis C virus(HCV) RNA-positive and abnormal liver function), or active infection requiring antimicrobial treatment (eg Treated with antibacterial drugs, antiviral drugs, antifungal drugs);6)renal insufficiency: urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g;7)Patients with seizures and need treatment.) 7. Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping. 8. Participated in other anti-tumor clinical trials within 4 weeks. 9. had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia; 10. were pregnant or breastfeeding.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-Sen Univerisity Guangzhou Guangdong

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05106777 on ClinicalTrials.gov ↗ ← All trials in China