SarcomaPhase 2NCT05106777
Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma
A Phase 2 study testing Surufatinib in people with Sarcoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Surufatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 10 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female, age14-70 years，the body surface area of patients under 18 years old is ≥1.5m2;
- Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic)；
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2).
- Life expectancy > 12 weeks.
- Have measurable disease based on RECIST 1.1.
Who cannot join
- Prior treatment with Surufatinib;
- 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.
- Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
- 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])
- had central nervous system metastasis;
- 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.)
Show all 10Show fewer
- Accepted surgical treatment, incision biopsy or significant traumatic injury within 28 days before grouping.
- Participated in other anti-tumor clinical trials within 4 weeks.
- had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
- were pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open Label Study of Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma
The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy.
Read the detailed description
The study population is patients with advanced osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy treatment. Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. Investigators will evaluate the clinical tumor response to Surufatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Surufatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Surufatinib with the agreement of the sponsor.
- Conditions
- Sarcoma
- Being tested
- Surufatinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Also called HMPL-012
Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib | Experimental | Drug: Surufatinib Surufatinib will be given orally. Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free rate at 12weeks
Measured: at 12weeks
Secondary outcomes (4)
Progression-free survival (PFS)
Measured: up to 12 months
Objective response rate (ORR)
Measured: up to 12 months
Disease control rate (DCR)
Measured: up to 12 months
Overall survival (OS)
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start10 Dec 2021
- Primary completion10 Dec 2025
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xing Zhang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106777
- Sponsor's protocol ID
- HMPL-012-SPRING-OS101
- Status last verified
- Apr 2026
- First submitted
- 25 Oct 2021
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label Study of Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT05106777
- Acronym / sponsor ID
- HMPL-012-SPRING-OS101
- Conditions
- Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to evaluate the effectiveness and safety of Surufatinib in patients with osteosarcoma and soft tissue sarcoma after Standard chemotherapy therapy.
Detailed description
The study population is patients with advanced osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy treatment. Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. Investigators will evaluate the clinical tumor response to Surufatinib, and if investigators determine that the patient can benefit from the continuation of treatment, the patient will continue the Surufatinib treatment. The duration of study will be 2 years. At the time of study completion, if investigators believe patients can continue to benefit from the investigational product, patients may be provided with Surufatinib with the agreement of the sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surufatinib | Experimental | Drug: SurufatinibDrug: Surufatinib Surufatinib will be given orally. |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female, age14-70 years，the body surface area of patients under 18 years old is ≥1.5m2;
- Histologically or cytologically confirmed advanced osteosarcoma and soft tissue sarcoma (unresectable or metastatic)；
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1 (amputation patients 0-2).
Key exclusion criteria (10 listed)
- Prior treatment with Surufatinib;
- 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.
- Symptoms that affect oral medication and can not be controlled through proper treatment. (such as inability to swallow, chronic diarrhoea and intestinal obstruction, etc.)
- 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])
- had central nervous system metastasis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurufatinibAlso: HMPL-012Surufatinib 300 mg once a day (QD) will be orally administrated on a 21-day cycle. | Drug | Surufatinib |
Primary outcome
Progression-free rate at 12weeks
Time frame: at 12weeks
4 secondary outcomes
Progression-free survival (PFS)
Time frame: up to 12 months
Objective response rate (ORR)
Time frame: up to 12 months
Disease control rate (DCR)
Time frame: up to 12 months
Overall survival (OS)
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Related trials for Sarcoma
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
Recruiting
Distance-Based Exercise to Preserve Function and Prevent Disability
Localized Malignant Solid Neoplasm, Anal Cancer
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
Recruiting
AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)
Cervical Cancer, Kaposi Sarcoma
Active, not recruiting
Clear Cell Chondrosarcoma in Italy
Chondrosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib in people with Sarcoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free rate at 12weeks (time frame: at 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.