OsteosarcomaPhase 2NCT05926492
A Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Osteosarcoma
A Phase 2 study testing Surufatinib plus chemotherapy and Chemotherapy in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Osteosarcoma
- What is being tested?
- Surufatinib plus chemotherapy and Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2024to Jul 2026
- Phase
- Phase 2
- 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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have fully understood the study and voluntarily signed the informed consent;
- Age from 2 to 70 years old (inclusive), both male and female;
- histologically or cytologically confirmed diagnosis of primary bone tumor
- having at least one measurable lesion (RECIST 1.1);
- The patient has not been treated before (including any chemotherapy, targeting, immune and other drugs);
- The functions of major organs and bone marrow are basically normal;
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- ECOG performance status 0 or 1 (PS 0-2 points for amputees);
- Expected survival ≥12 weeks;
- Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value ≥1.5×109/L, platelets ≥100×109/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);
- 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 the female patient has undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or radiation of the ovary).
Who cannot join
- Patients who have previously received chemotherapy drugs, surufatinib, or other antiangiogenic agents;
- Received approved or under development systematic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, etc.;
- 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 prothrombin time (APTT) > 1.5×ULN;
- The investigator identified clinically significant electrolyte abnormalities;
- The patient currently has hypertension that cannot be controlled by drugs, as follows: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
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- Unsatisfactory blood glucose control (FBG > 10 mmol/L);
- The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take surufatinib orally;
- The patient currently has gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected 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 >30 mL within 3 months , hematemesis, stool, stool blood), hemoptysis ( > 5 mL of fresh blood within 4 weeks) 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; New York Heart Association (NYHA) Grades for Congestive Heart Failure was > level 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) Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (> 1×104 copies /mL or > 2000 IU/ml) must be excluded for known hepatitis B virus (HBV) carriers; 3) Known hepatitis C virus infection (HCV) and HCV RNA positive (> 1×103 copies /mL), or other hepatitis, cirrhosis;
- The patient has current central nervous system (CNS) metastases or previous brain metastases;
- 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;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk;
- Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein quantification >1.0g.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhaoming Ye, M.D., 0086 13606501549, yezhaoming@zju.edu.cn
About this study
Official title: A Prospective, Multicenter, Non-randomized Controlled Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Patients With Osteosarcoma
This phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy.
Read the detailed description
Surufatinib is a potent inhibitor of colony-stimulating factor 1 receptor（CSF-1R）, which shows a promising tumor inhibition effect on sarcoma. This is a prospective, multicenter, controlled phase II study to explore the efficacy and safety of surufatinib combined with chemotherapy in neoadjuvant treatment of osteosarcoma. In this study, 160 patients were enrolled into the following treatment groups with a 1:1 ratio: (1) Surufatinib + chemotherapy group (N=80) (2) control group: chemotherapy group (N=80); A 30-day treatment cycle was performed, the efficacy was evaluated after 2 cycles of neoadjuvant therapy. The primary endpoints were tumor necrosis rate, and secondary endpoints were 1-year progression-free survival (PFS) and drug safety.
- Conditions
- Osteosarcoma
- Being tested
- Surufatinib plus chemotherapy, Chemotherapy
- Medical subject headings
- Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib plus chemotherapyDrug
Also called Arm A
Surufatinib: (1) for patients aged > 21 years old and ≤70 years old, surufatinib 200 mg, qd, oral, continuous administration; (2) For patients aged ≥2 years and ≤21 years, starting from the low dose of patient BSA (body surface area), Stevenson's formula developed according to the Chinese population was used: BSA = 0.0061H+0.0128W-0.1529 (H: BSA = 0.0061H+0.0128W-0.1529). Height /cm; W: body weight /kg); Chemotherapy : 1) Doxorubicin 60 mg/m2, or liposome doxorubicin 45mg/ m2, day 17; 2) Cisplatin: 100 mg/m2, day 15; 3) Ifosfamide; 2.5g/m2, day 8-12;
The above drugs were used in turn, and 30 days were regarded as a treatment cycle.
ChemotherapyDrug
Also called Arm B
- High-dose methotrexate : 8-12 g/m2 (MTX chemotherapy requires blood drug concentration monitoring), day 1 and 8; 2) Doxorubicin 60 mg/m2 or liposomal doxorubicin 45mg/ m2, day 17; 3) Cisplatin: 100 mg/m2, day 15;4) Ifosfamide; 2.5 g/m2, day 8-12.
The above drugs were used in turn, and 30 days were regarded as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib plus chemotherapy | Experimental | Patients were to receive surufatinib plus chemotherapy every 30 days as neoadjuvant treatment. After receiving 2 cycles of treatment, patients will be evaluated for tumor necrosis rate. Receives: Drug: Surufatinib plus chemotherapy |
| Chemotherapy | Active comparator | Patients were to receive chemotherapy every 30 days as neoadjuvant treatment. After receiving 2 cycles of treatment, patients will be evaluated for tumor necrosis rate. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor cell necrosis rate (TCNR)
The percentage of patients with tumor cell necrosis > 90% was assessed according to Huvos
Measured: 12 months
Secondary outcomes (2)
1 year Progression-free survival (PFS) rate
The proportion of patients who were free from disease progression or death from any cause within 1 year from enrollment.
Measured: 1 year
All adverse event/Serious adverse event that occurred during the study period according to CTCAE 5.0
Safety analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start9 Jan 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926492
- Sponsor's protocol ID
- 2023-0425
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Non-randomized Controlled Clinical Study of Surufatinib Combined With Chemotherapy as Neoadjuvant Treatment in Patients With Osteosarcoma
- ClinicalTrials.gov ID
- NCT05926492
- Acronym / sponsor ID
- 2023-0425
- Conditions
- Osteosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 3 Jul 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 phase II study aims to explore the tumor necrosis rate in osteosarcoma patients treated with a neoadjuvant regimen of surufatinib combined with chemotherapy.
Detailed description
Surufatinib is a potent inhibitor of colony-stimulating factor 1 receptor（CSF-1R）, which shows a promising tumor inhibition effect on sarcoma. This is a prospective, multicenter, controlled phase II study to explore the efficacy and safety of surufatinib combined with chemotherapy in neoadjuvant treatment of osteosarcoma. In this study, 160 patients were enrolled into the following treatment groups with a 1:1 ratio: (1) Surufatinib + chemotherapy group (N=80) (2) control group: chemotherapy group (N=80); A 30-day treatment cycle was performed, the efficacy was evaluated after 2 cycles of neoadjuvant therapy. The primary endpoints were tumor necrosis rate, and secondary endpoints were 1-year progression-free survival (PFS) and drug safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surufatinib plus chemotherapy | Experimental | Drug: Surufatinib plus chemotherapyPatients were to receive surufatinib plus chemotherapy every 30 days as neoadjuvant treatment. After receiving 2 cycles of treatment, patients will be evaluated for tumor necrosis rate. |
| Chemotherapy | Active comparator | Drug: ChemotherapyPatients were to receive chemotherapy every 30 days as neoadjuvant treatment. After receiving 2 cycles of treatment, patients will be evaluated for tumor necrosis rate. |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Have fully understood the study and voluntarily signed the informed consent;
- Age from 2 to 70 years old (inclusive), both male and female;
- histologically or cytologically confirmed diagnosis of primary bone tumor
- having at least one measurable lesion (RECIST 1.1);
- The patient has not been treated before (including any chemotherapy, targeting, immune and other drugs);
Key exclusion criteria (19 listed)
- Patients who have previously received chemotherapy drugs, surufatinib, or other antiangiogenic agents;
- Received approved or under development systematic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, radical radiotherapy, biological immunotherapy, targeted therapy, etc.;
- 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 prothrombin time (APTT) > 1.5×ULN;
- The investigator identified clinically significant electrolyte abnormalities;
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 |
|---|---|---|
| Surufatinib plus chemotherapyAlso: Arm ASurufatinib: (1) for patients aged > 21 years old and ≤70 years old, surufatinib 200 mg, qd, oral, continuous administration; (2) For patients aged ≥2 years and ≤21 years, starting from the low dose of patient BSA (body surface area), Stevenson's formula developed according to the Chinese population was used: BSA = 0.0061H+0.0128W-0.1529 (H: BSA = 0.0061H+0.0128W-0.1529). Height /cm; W: body weight /kg); Chemotherapy : 1) Doxorubicin 60 mg/m2, or liposome doxorubicin 45mg/ m2, day 17; 2) Cisplatin: 100 mg/m2, day 15; 3) Ifosfamide; 2.5g/m2, day 8-12; The above drugs were used in turn, and 30 days were regarded as a treatment cycle. | Drug | Surufatinib plus chemotherapy |
| ChemotherapyAlso: Arm B1) High-dose methotrexate : 8-12 g/m2 (MTX chemotherapy requires blood drug concentration monitoring), day 1 and 8; 2) Doxorubicin 60 mg/m2 or liposomal doxorubicin 45mg/ m2, day 17; 3) Cisplatin: 100 mg/m2, day 15;4) Ifosfamide; 2.5 g/m2, day 8-12. The above drugs were used in turn, and 30 days were regarded as a treatment cycle. | Drug | Chemotherapy |
Primary outcome
Tumor cell necrosis rate (TCNR)
Time frame: 12 months
The percentage of patients with tumor cell necrosis > 90% was assessed according to Huvos
2 secondary outcomes
1 year Progression-free survival (PFS) rate
Time frame: 1 year
All adverse event/Serious adverse event that occurred during the study period according to CTCAE 5.0
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
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 plus chemotherapy and Chemotherapy in people with Osteosarcoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 10 inclusion and 19 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 17 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghao Li, PhD (+86-17764527695, libinghaohz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor cell necrosis rate (TCNR) (time frame: 12 months). 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 17 Apr 2024.