Small round cell sarcoma
Conditions
Interventions
Experimental group:Irinotecan Liposome Combined with Erlotinib Treatment Group
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 14 years or older, any gender; 2. Unresectable small round cell sarcoma with metastasis or recurrence that has failed first-line standard treatment confirmed by histology or cytology and requiring second-line or later treatment; 3. At least one measurable lesion by imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1); 4. ECOG performance status 0-2; 5. Expected survival of more than 3 months; 6. Good organ function, subjects must meet the following laboratory criteria: (1) Absolute neutrophil count (ANC) >=1.5×10^9/L without use of granulocyte-colony stimulating factors in the past 14 days; (2) Platelets >=90×10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin >9 g/dL without blood transfusion in the past 14 days; (4) Total bilirubin =40 ml/min; 7. Female subjects of childbearing potential must have a urine or serum pregnancy test within 3 days before the first administration of the study drug (Cycle 1, Day 1) with a negative result. If the urine pregnancy test cannot be confirmed negative, a blood pregnancy test is required. Non-childbearing women are defined as those postmenopausal for at least one year, or have undergone surgical sterilization or hysterectomy; 8. If at risk of pregnancy, all subjects (male or female) must use contraception with a failure rate of less than 1% during the entire treatment period and for 120 days after the last administration of the study drug; 9. Able to understand and sign the written informed consent form; expected to have good compliance.
Exclusion criteria
Exclusion criteria: 1. There was >= 2 grade peripheral neuropathy (CTCAE v5.0, due to the risk of neurotoxicity associated with eribulin). 2. There are patients with severe liver dysfunction; 3. Has previously received treatment with irinotecan, irinotecan liposome, or epirubicin; 4. Those who are allergic to irinotecan, irinotecan liposome, epirubicin and excipients; 5. Uncontrolled cardiovascular diseases (such as QTc interval > 500 ms, NYHA class III/IV heart failure); 6. Active infections (requiring intravenous antibiotics/antifungal treatment) or active HIV/HBV/HCV infections (unless viral load is suppressed); 7. Received any other experimental drugs or underwent major surgery within 4 weeks; 8. Must not discontinue the use or not discontinue the use within 2 weeks before enrollment of CYP3A, CYP2C8 and UGT1A1 inhibitors or inducers (anticonvulsants [phenytoin, phenobarbital or carbamazepine], rifampicin, rifabutin, St. John’s Wort, grapefruit juice, clarithromycin, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, teraprevir, voriconazole, abacavir, gatifloxacin, indinavir, etc.); 9. Pregnant or lactating female patients, and patients of childbearing age who refuse to use contraceptive measures; 10. History of other malignant tumors (having suffered from any other non-in situ malignant tumors within the past 5 years or currently, excluding non-melanoma skin cancer and thyroid micro-papillary carcinoma); 11. Those who, in the judgment of the researchers, were not suitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity (DLT);Overall Survival (OS);16-week progression-free survival rate (PFSR);Safety;Disease Control Rate (DCR);Objective response rate(ORR); | — |
Countries
China
Contacts
Public ContactMeiyu Fang
Zhejiang Cancer Hospital
Outcome results
None listed