New drug hope for rare sarcomas after chemo fails
NCT ID NCT05106777
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a daily oral drug called surufatinib in 47 people with advanced osteosarcoma or soft tissue sarcoma that has not responded to standard chemotherapy. The goal is to see if the drug can slow tumor growth and improve survival. Participants take the drug in 21-day cycles, and researchers track how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Surufatinib (a drug taken by mouth once daily in 21-day cycles)
- What this could lead to
- If successful, surufatinib could offer a new treatment option for people with advanced sarcoma who have run out of standard chemotherapy options.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 47 participants, so results may not apply to everyone. The drug may not work better than existing treatments and could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 47 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sun Yat-Sen Univerisity
Guangzhou, Guangdong, China
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Other studies related to the condition(s) this trial covers.
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