Sarcoma
Conditions
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Have fully understood the study and voluntarily signed the informed consent form; 2. Patients aged 15 = 1.5m2; 3. Patients with histologically or cytologically confirmed unresectable stage IIB-IV advanced leiomyosarcoma or liposarcoma; 4. Patients must have at least one measurable lesion (RECIST 1.1) 5. ECOG PS score: 0-1 points (PS 0-2 points for amputees); 6. Expected survival >= 3 months; 7. Patients have experienced at least first-line systemic treatment failure in the past, which is defined as: disease progression during treatment or within 6 months after the last treatment; or the toxic side effects during treatment are intolerable. (Note: Neoadjuvant or adjuvant therapy is allowed in the early stage, and neoadjuvant or adjuvant therapy is considered to be first-line standard therapy for progressive disease if disease progression/recurrence occurs during or within 6 months of the end of neoadjuvant or adjuvant therapy.) ) 8. Normal function of major organs, that is, meeting the following criteria: 1) Routine blood examination (no blood transfusion within 14 days, no use of hematopoietic stimulating factor drugs to correct the state): hemoglobin (Hb) >= 90g/L; Absolute neutrophil count (ANC) >= 1.0×10^9/L; Platelets (PLT) >= 75×10^9/L; White blood cell count (WBC) >= 3.0×10^9/L; 2) Biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 50ml/min; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%; 9. Women of childbearing age should agree to use contraception (such as intrauterine device [IUD], birth control pills, or condoms) during the study and for 6 months after the end of the study; Negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating subjects; Males should be subjects who agree that contraception must be used during the study and for 6 months after the end of the study period; 10. Ability of the young patient's parent/guardian to understand, consent, and sign the study informed consent form (ICF) prior to initiation of any project-related procedures; Subjects may express assent with parental/guardian assent, if applicable.
Exclusion criteria
Exclusion criteria: 1. Previously received treatment with immune checkpoint inhibitors (including but not limited to pembrolizumab, nivolumab) or lenvatinib; 2. Underwent anticancer therapy within 28 days before chemotherapy or within five half-lives of small molecule targeted drugs (whichever is shorter), or any investigational drug treatment within 30 days; 3. Underwent major surgery, open biopsy, or serious trauma within 4 weeks before enrollment; 4. Used immunosuppressive drugs within 14 days before starting treatment, excluding intranasal or inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., prednisone 1.5 or activated partial thromboplastin time (APTT) >1.5×ULN; 7. Current uncontrolled hypertension despite medication, defined as: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 8. Participants with proteinuria greater than 1 on urinalysis will undergo 24-hour urine collection for quantitative assessment, and those with urinary protein >= 1 g/24 hours will be excluded from the study; 9. Presence of any condition or disease affecting drug absorption, or inability to take lenvatinib orally; 10. Current active gastrointestinal diseases such as gastric or duodenal ulcers, ulcerative colitis, or untreated tumors with active bleeding, or any other condition deemed by the investigator to potentially cause gastrointestinal bleeding or perforation; 11. Evidence or history of significant bleeding tendency within 3 months before enrollment (bleeding >30 mL in 3 months, hematemesis, melena, hematochezia), hemoptysis (fresh blood >5 mL 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 before enrollment; congestive heart failure NYHA class >2; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) = CTCAE v5.0 grade 2 infection); 15. Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis [patients known to be hepatitis B virus (HBV) carriers must exclude active HBV infection, i.e., HBV DNA positive (above the normal detection limit; >1×10^4 copies/mL or >2000 IU/mL); known hepatitis C virus (HCV) infection with HCV RNA positive (>1×10^3 copies/mL), or other hepatitis, cirrhosis] (excluding patients whose relevant test results have returned to normal after previous antiviral treatment); 16. Patients with unstable or symptomatic brain metastases; 17.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;Time to relief;Duration of relief;Objective Response Rate;Overall survival;Incidence of adverse events (AEs) and serious adverse events (SAEs);Severity of adverse events (AEs) and serious adverse events (SAEs);Abnormal laboratory values;Dose interruption rate caused by AE;Dose reduction rate caused by AE;Dose discontinuation rate due to AE;Mortality caused by AE; | — |
Countries
China
Contacts
Public ContactHu Haiyan
Shanghai Sixth People's Hospital
Outcome results
None listed