Small Cell Lung Cancer Clinical Trial
Official title:
The Therapeutic Effect of Irinotecan Liposomes Combined With Cisplatin/Carboplatin for Platinum Sensitive Recurrent Small Cell Lung Cancer
Verified date | June 2024 |
Source | Tang-Du Hospital |
Contact | Haichuan Su, PhD |
Phone | 18629190366 |
such[@]fmmu.edu.cn | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | September 15, 2028 |
Est. primary completion date | September 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - The patient fully understands this study, voluntarily participates and signs an informed consent form (ICF). - Age = 18 years old; - Patients with extensive stage small cell lung cancer diagnosed by pathology or histology; - According to RECIST 1.1 standard, patients have at least one measurable target lesion; For lesions that have undergone radiation therapy in the past, they can only be included as measurable lesions if there is clear disease progression after radiation therapy; - Progression confirmed by imaging examination after 6 months of first-line radiotherapy and chemotherapy containing platinum drugs or platinum regimen radiotherapy and chemotherapy ± immunotherapy; - Eastern Cancer Collaborative Group (ECOG) physical fitness score: 0-2 points; - Estimated survival time = 3 months; - Absolute neutrophil count (ANC) = 1.5 x 10 ^ 9/L, platelet count = 90 x 10 ^ 9/L, and hemoglobin count = 90 g/L (no blood transfusion, blood products, use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 14 days prior to laboratory examination); - Liver and kidney function: serum creatinine = 1.5 times the upper limit of normal value; AST and ALT = 2.5 times the upper limit of normal values (= 5 times the upper limit of normal values for patients with liver invasion); Total bilirubin = 1.5 times the upper limit of normal value (= 3 times the upper limit of normal value for patients with liver invasion); - Women of childbearing age must undergo a pregnancy test (serum) within 7 days before enrollment, and the result is negative. They are willing to use appropriate methods of contraception during the trial period and 6 months after the last administration of the trial drug; Exclusion Criteria: - Patients with large cell neuroendocrine tumors and mixed small cell carcinoma; - Patients with active brain metastasis or central nervous system invasion confirmed by imaging evaluation and/or biopsy (prednisone equivalent dose = 10mg); - There is an hypersensitivity reaction to any investigational drug or its components; - Severe uncontrolled concurrent infections or other serious uncontrolled concomitant diseases, moderate or severe kidney injury; (such as progressive infection, uncontrollable hypertension, diabetes, etc.); - Heart function and disease meet one of the following conditions: 1. Long QTc syndrome or QTc interval>480 ms; 2. Complete left bundle branch block, II or III degree atrioventricular block; 3. Severe and uncontrolled arrhythmias that require medication treatment; 4. The New York College of Cardiology has a classification of = III; 5. Cardiac ejection fraction (LVEF) below 50%; 6. A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to recruitment. - Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen is positive and hepatitis B B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL); - Human Immunodeficiency Virus (HIV) infection (HIV antibody positive); - Has previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled within the past five years); - Pregnant and lactating women, as well as patients of childbearing age who are unwilling to take contraceptive measures; - Patients with other malignant tumors that require treatment; The researchers determined that patients who are not suitable to participate in this study. |
Country | Name | City | State |
---|---|---|---|
China | Tangdu Hospital | Xi'an | Shannxi |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intracranial Objective response rate | Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using Investigator assessments, is defined as the number (%) of patients with response of Complete Response or Partial Response, will be assessed up to 1 years. | Data obtained up until progression, or the last evaluable assessment in the absence of progression, will be assessed up to 1 years. | |
Secondary | Progression-free survival | Progression free survival (PFS) refers to the time from recording the first chemotherapy treatment to the date of disease progression, as assessed by researchers. | Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years | |
Secondary | Duration of Response | Duration of Response(DoR)refers to the time from the first assessment as CR or PR to the first assessment as PD or (due to any reason) death | Duration of Response(DoR)analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 4 years | |
Secondary | Overall Survival | Overall survival (OS) refers to the time that researchers evaluate from recording the first chemotherapy to death (of any cause). | The maximum time from receiving treatment to dying for any reason is 4 years. | |
Secondary | Safety/Adverse event | Incidence of Adverse Events (AEs): Incidence, severity and seriousness of adverse events, incidence of serious adverse events (SAEs), which usually be graded by CTCAE v5.0 based on current clinical practice. | From the first recorded chemotherapy to 4 weeks after the last recorded chemotherapy |
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