Advanced or metastatic B2, B3 thymoma and thymic cancer
Conditions
Interventions
Trial group:A Simon two-stage optimal design is employed: 9 patients are enrolled in stage 1
if >=1 response is observed, the study proceeds to stage 2 (total of 17 patients)
if >=3 responses are observed in total, the study is considered successful. Surufatinib is administered at a dose of 300 mg orally once daily, with a 4-week cycle, continued until unacceptable toxicit
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. The subjects voluntarily joined this study and signed an informed consent form 3. Confirmed by pathological histology or cytology: patients with advanced recurrent or metastatic B2, B3 thymoma and thymic carcinoma who have failed at least one line of chemotherapy and are not eligible for surgical resection or curative radiotherapy 4. Definition of treatment failure: disease progression or intolerable toxicity during or after first-line systemic chemotherapy (including platinum-based regimens); for neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), disease progression during or within 6 months after cessation of treatment shall be considered as first-line treatment failure 5. Age >=18 years 6. ECOG performance status: 0-2 7. Expected survival >=12 weeks 8. At least one measurable lesion (according to RECIST 1.1 criteria) 9. Main organ and bone marrow functions are basically normal 10. Complete blood count: white blood cells >=4.0×10^9/L, neutrophils >=1.5×10^9/L, platelets >=100×10^9/L, hemoglobin >=90 g/L 11. International normalized ratio (INR) =50 mL/min (Cockcroft-Gault formula) 14. Normal cardiac function, left ventricular ejection fraction (LVEF) >=50% by two-dimensional echocardiography
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received anti-VEGFR inhibitors or anti-angiogenesis-targeted therapy 2. Patients who participated in other anti-tumor drug clinical trials within 4 weeks prior to enrollment or are currently enrolled in other clinical trials 3. Patients with any other malignancy diagnosed within the past 5 years, except for completely resected basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ 4. Patients with current central nervous system (CNS) metastases or a history of brain metastases with control duration of less than 2 months 5. Patients with any condition affecting drug absorption, or who are unable to orally take surufatinib 6. Patients who received strong CYP3A4 inducers or inhibitors within 2 weeks prior to first study drug administration 7. Patients who underwent any surgery (except biopsy) or invasive treatment/procedure within 4 weeks prior to enrollment, with unhealed surgical incisions (excluding venous catheterization, drainage puncture, etc.) 8. Patients with uncontrolled hypertension defined as: hypertension inadequately controlled by a single antihypertensive agent (systolic BP >=150 mmHg, diastolic BP >=100 mmHg); or patients requiring two or more antihypertensive drugs to control blood pressure 9. Patients with urine dipstick protein >=2+ and 24-hour urinary protein >1.0 g 10. Patients with active gastric or duodenal ulcers, ulcerative colitis, or other gastrointestinal diseases, or unremoved tumors with active bleeding, or other conditions deemed by the investigator to potentially cause gastrointestinal bleeding or perforation 11. Patients with significant bleeding tendency or history within 3 months prior to enrollment (bleeding >30 mL, hematemesis, melena, hematochezia), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events within the past 12 months (including stroke and/or transient ischemic attack) 12. Clinically significant cardiovascular disease, including but not limited to: acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with NYHA class >2; arrhythmias requiring pharmacological treatment; ECG showing QTc interval >=480 ms 13. Active or uncontrolled severe infection (>=CTCAE grade 2) 14. Pregnant women (positive pregnancy test prior to dosing) or breastfeeding women 15. Other clinically significant diseases, metabolic abnormalities, physical examination findings, or laboratory abnormalities that the investigator deems unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Disease control rate (DCR);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactXu Bei
Zhongshan Hospital, Fudan University
Outcome results
None listed