Soft Tissue Sarcoma AdultNCT06110650
A Study of Surufatinib in the Treatment of Advanced Soft Tissue Sarcoma
A study testing Surufatinib in people with Soft Tissue Sarcoma Adult, run by Fudan University.
Trial summary
This is a single-center, open, single-arm, phase II clinical study to investigate the efficacy and safety of patients with soft tissue sarcoma who have failed anthracycline-containing chemotherapy and whose antivascular agents have been effective and failed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma Adult
- 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
- 29 participants
- Where
- No sites listed yet
- Study dates
- 28 Nov 2023to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have fully understood the study and voluntarily signed the informed consent;
- Age ≥18 years old;
- Histologically or cytologically confirmed patients with unresectable or metastatic soft tissue sarcoma;
- The patient must have at least one measurable lesion (RECIST1.1);
- Previous failure of anthracycline-containing chemotherapy was defined as disease progression during treatment or within 3 months after the last treatment, or disease progression during adjuvant treatment with anthracycline-containing chemotherapy or within 6 months after adjuvant treatment, and toxic side effects of anthracycline-containing chemotherapy were not tolerated. (Neoadjuvant or adjuvant chemotherapy is allowed in the early stage. If disease progression/recurrence occurs during neoadjuvant/adjuvant therapy or within 6 months after the end of treatment, neoadjuvant/adjuvant therapy is considered a failure of first-line systemic chemotherapy for progressive disease);
- Patients with previous anti-angiogenic efficacy and failure were defined as: tumor progression occurred in SD or above patients after withdrawal of SD (CR/PR) during the course of anti-angiogenic therapy (including anti-angiogenic small molecule inhibitors or monoclonal antibodies), or tumor progression occurred in SD patients over 12 weeks; Or the toxic side effects of treatment are intolerable.
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- ECOG physical status 0 or 1 points (PS0-2 points for amputees);
- Expected survival ≥12 weeks;
- Blood test (without blood transfusion within 14 days)
- 1) Neutrophil absolute value ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin concentration ≥9g/dL);
- 2) Liver function test (aspartate aminotransferase and glutamic aminotransferase ≤2.5×ULN, total bilirubin ≤1.5×ULN; In case of liver metastasis, AST and ALT≤5×ULN);
- 3) Renal function (serum creatinine ≤1.5×ULN, creatinine clearance (CCr)≥60ml/min)
- 10. 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 within 6 months of the last study dose. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or irradiation of radioactive ovaries).
Who cannot join
- Patients who have received previous treatment with Surufatinib;
- Consider toxic reactions associated with anti-vascular targeting drugs if they have previously been intolerable
- Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
- 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 prohemase time (APTT)>1.5×ULN;
- The investigator identified clinically significant electrolyte abnormalities;
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- The patient currently has high blood pressure that cannot be controlled by drugs, which is defined as: systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg;
- Unsatisfactory blood glucose control (FBG > 10mmol/L);
- The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take sofantinib orally;
- The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresectosed tumors, or other conditions determined by researchers that may cause gastrointestinal bleeding or perforation;
- Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months >30mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks >5mL of fresh blood) or had a thromboembolic event (including stroke events and/or transient ischemic attacks) within 12 months;
- 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 enrollment; Congestive Heart Failure New York Heart Association (NYHA) Grades > Lv.2; Ventricular arrhythmias requiring medical treatment; LVEF(Left ventricular Ejection Fraction)<50%;
- 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) A known history of clinically significant liver disease, including viral hepatitis A known hepatitis B virus (HBV) carrier must rule out active HBV infection, i.e., positive HBVDNA (>1×10^4 copies /mL or >2000IU/ml);
- 3) Known hepatitis C virus infection (HCV) and HCVRNA positive (>1×10^3 copies /mL), or other hepatitis, cirrhosis;
- 15. The patient has current central nervous system (CNS) metastases or previous brain metastases;
- 16. 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;
- 17. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- 18. Any other medical condition, a clinically significant metabolic abnormality, abnormal physical examination, or abnormal laboratory examination, which, in the investigator's judgment, reasonably suspects the patient to have a medical condition or condition that is not suitable for the use of the investigational drug (such as the presence of epileptic seizures requiring treatment), or which would affect the interpretation of the study results, or place the patient at a high risk;
- 19. Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein quantification > 1.0g.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single-arm, Single-center, Exploratory Phase II Study of Surufatinib in Patients With Soft Tissue Sarcoma Who Have Failed Anthracycline-containing Chemotherapy and Who Have Been Successfully Targeted With Antivascular Agents
This is a single-center, open, single-arm, phase II clinical study to investigate the efficacy and safety of patients with soft tissue sarcoma who have failed anthracycline-containing chemotherapy and whose antivascular agents have been effective and failed.
Progression-free survival (PFS) was used as the primary outcome measure to preliminatively estimate the efficacy and safety of 29 patients with soft tissue sarcoma who had failed chemotherapy with anthracyclines and who had received effective and failed antivascular agents. Sofantinib 300mg orally, once a day, with continuous administration every 21 days, until the disease progresses or becomes intolerable; Imaging methods were used every 6 weeks (±7 days) after enrollment according to RECIST1.1 standard to evaluate the efficacy of tumor.
- Conditions
- Soft Tissue Sarcoma Adult
- Being tested
- Surufatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurufatinibDrug
Surufatinib 300mg orally, once a day, every 21 days for one cycle, treatment until disease progression or intolerance
| Study group | Role | What they receive |
|---|---|---|
| surufatinib | Experimental | surufatinib 300mg orally, once a day, every 21 days for one cycle, treatment until disease progression or intolerance Receives: Drug: Surufatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression-free survival
Measured: PFS is defined as approximately 12 months from the date of enrollment until the date of first recorded progress or the date of death from any cause, whichever comes first
Secondary outcomes (3)
ORR
Objective Response Rate
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
Overall Survival
Measured: OS From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
DCR
Disease Control Rate
Measured: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start28 Nov 2023 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma AdultStudies of the same condition, open and under way.
- More trials run by Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110650
- Sponsor's protocol ID
- 2306276-6
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center, Exploratory Phase II Study of Surufatinib in Patients With Soft Tissue Sarcoma Who Have Failed Anthracycline-containing Chemotherapy and Who Have Been Successfully Targeted With Antivascular Agents
- ClinicalTrials.gov ID
- NCT06110650
- Acronym / sponsor ID
- 2306276-6
- Conditions
- Soft Tissue Sarcoma Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 31 Oct 2023 (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.
This is a single-center, open, single-arm, phase II clinical study to investigate the efficacy and safety of patients with soft tissue sarcoma who have failed anthracycline-containing chemotherapy and whose antivascular agents have been effective and failed.
Progression-free survival (PFS) was used as the primary outcome measure to preliminatively estimate the efficacy and safety of 29 patients with soft tissue sarcoma who had failed chemotherapy with anthracyclines and who had received effective and failed antivascular agents. Sofantinib 300mg orally, once a day, with continuous administration every 21 days, until the disease progresses or becomes intolerable; Imaging methods were used every 6 weeks (±7 days) after enrollment according to RECIST1.1 standard to evaluate the efficacy of tumor.
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: Surufatinibsurufatinib 300mg orally, once a day, every 21 days for one cycle, treatment until disease progression or intolerance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have fully understood the study and voluntarily signed the informed consent;
- Age ≥18 years old;
- Histologically or cytologically confirmed patients with unresectable or metastatic soft tissue sarcoma;
- The patient must have at least one measurable lesion (RECIST1.1);
- Previous failure of anthracycline-containing chemotherapy was defined as disease progression during treatment or within 3 months after the last treatment, or disease progression during adjuvant treatment with anthracycline-containing chemotherapy or within 6 months after adjuvant treatment, and toxic side effects of anthracycline-containing chemotherapy were not tolerated. (Neoadjuvant or adjuvant chemotherapy is allowed in the early stage. If disease progression/recurrence occurs during neoadjuvant/adjuvant therapy or within 6 months after the end of treatment, neoadjuvant/adjuvant therapy is considered a failure of first-line systemic chemotherapy for progressive disease);
Key exclusion criteria (22 listed)
- Patients who have received previous treatment with Surufatinib;
- Consider toxic reactions associated with anti-vascular targeting drugs if they have previously been intolerable
- Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;
- 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 prohemase time (APTT)>1.5×ULN;
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 |
|---|---|---|
| SurufatinibSurufatinib 300mg orally, once a day, every 21 days for one cycle, treatment until disease progression or intolerance | Drug | surufatinib |
Primary outcome
PFS
Time frame: PFS is defined as approximately 12 months from the date of enrollment until the date of first recorded progress or the date of death from any cause, whichever comes first
progression-free survival
3 secondary outcomes
ORR
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
Time frame: OS From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
DCR
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Surufatinib in people with Soft Tissue Sarcoma Adult, run by Fudan University.
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 13 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaowei zhang (15921521116, dongfangzhizizhxw@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: PFS is defined as approximately 12 months from the date of enrollment until the date of first recorded progress or the date of death from any cause, whichever comes first). 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 31 Oct 2023.