Small cell lung cancer
Conditions
Interventions
immunotherapy:Irinotecan hydrochloride liposomal injection (II) (70 mg/m^2, intravenous infusion, D1, Q3W, the investigator can adjust the dose according to the patients own situation, in principle, n
Sponsors
The second hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Study participants must meet all of the following inclusion criteria to be enrolled in this trial: 1. Age: >=18 years old, both male and female; 2. Patients with histologically or cytologically confirmed small cell lung cancer; 3. Patients with ES-SCLC who have failed prior first-line standard therapy; 4. ECOG score: 0-1 points; 5. Life expectancy=3 months; 6. Have at least one measurable lesion as the target lesion according to the efficacy evaluation criteria 1.1 in solid tumors (lesions that have received radiotherapy within 6 months before the first dose cannot be used as the target lesion); 7. No untreated brain metastases or stable condition after treatment>=1 month; 8. Good function of major organs: a) Neutrophil count (ANC) > = 1.5 × 10^9/L; b) Platelet count (PLT) > = 100×10^9/L; c) hemoglobin (Hb) >=90 g/L; d) creatinine = 50 mL/min (using the Chockcroft-Gault formula for creatinine clearance); e) total bilirubin (BIL) <=1.5 times the upper limit of normal (ULN); f) aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels < = 2.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels < = 5 times the upper limit of normal (ULN) if liver metastases are comorbid; g) International normalized ratio (INR) < = 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) < = 1.5 times ULN; 9. Female study participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose and not be lactating, and study participants and their partners must use effective contraception during the trial and for 6 months after the last dose of trial drug; 10. With the consent of the individual and have signed the informed consent form, willing and able to comply with the planned visits, study treatments, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: Those who have one of the following conditions cannot participate in the clinical study: 1. Known hypersensitivity to irinotecan hydrochloride liposomal injection (II) and ivoximab or drug excipients; 2. Have any active autoimmune disease (such as uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy), tuberculosis); Skin conditions (e.g., vitiligo, psoriasis, or alopecia) that have been in complete remission of childhood asthma and do not require any intervention in adulthood and do not require systemic treatment may be included; 3. Participated in other drug studies within 4 weeks prior to enrollment; 4. The imaging during the screening period shows that the tumor surrounds important blood vessels or has obvious necrosis and cavitation, and the investigator judges that entering the study will cause a risk of bleeding; 5. History of major illness within 1 year prior to the first dose, specifically: unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association NYHA classification = grade 2) or vascular disease (such as aortic aneurysm with risk of rupture) within 12 months prior to the first dose, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia, etc.); 6. History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistulas, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to the first dose; 7. Those who have had a major surgical procedure or serious traumatic injury within 4 weeks prior to the first dose, or who have a major surgical procedure planned within 4 weeks after the first dose (at the discretion of the investigator); Minor local surgery within 3 days prior to the first dose (excluding peripherally venipuncture central venous catheterization and intravenous port implantation); 8. Have a history of severe bleeding tendency or coagulation dysfunction; Clinically significant bleeding symptoms within 4 weeks prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or coughing up >=1 teaspoon of fresh blood or small blood clots or coughing up blood without sputum, those with blood in sputum are allowed to be enrolled), nasal bleeding (excluding epistaxis hemorrhage and retracting rhinohema); Ongoing antiplatelet or anticoagulant therapy within 14 days prior to the first dose; 9. Subjects who have received or plan to receive a live vaccine within 4 weeks prior to the first dose of study drug (Note: Inactivated virus vaccine for injectable use against seasonal influenza within 30 days of the first dose is allowed; However, intranasal administration of live attenuated vaccines is not permitted) 10. Diagnosis of any other malignancy within 3 years prior to study entry, with the exception of adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix; 11. Patients who are known to have a history of psychotropic drug abuse or drug abuse, or have other serious physical or psychiatric diseases or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and are judged by the investigator to be unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;Adverse event; | — |
Countries
China
Contacts
Public ContactDai Zhaoxia
The Second Affiliated Hospital of Dalian Medical University
Outcome results
None listed