Clinical trial NCT05106777: Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma
Official title: A Multi-center, Open Label Study of Surufatinib in Patients With Osteosarcoma and Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sarcoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 47
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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 outcomes:
measure: Progression-free rate at 12weeks
timeFrame: at 12weeks
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: up to 12 months
measure: Objective response rate (ORR)
timeFrame: up to 12 months
measure: Disease control rate (DCR)
timeFrame: up to 12 months
measure: Overall survival (OS)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Univerisity
state: Guangdong
Study officials:
References: