Small Cell Lung Cancer (SCLC)
Conditions
Interventions
Experimental group:Irinotecan liposome (II) combined with ivonescimab
Sponsors
Shengjing Hospital of China Medical University/The Second Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years old, both male and female; 2. Patients with histologically or cytologically confirmed small-cell lung cancer; ES-SCLC patients who failed previous first-line standard therapy; 3. 4.ECOG score: 0-1; 5. Life expectancy >=3 months; 6. According to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST v1.1), at least one measurable lesion was used as the target lesion (lesions that received radiotherapy within 6 months before the first dose were not used as the target lesion); 7. No untreated brain metastases or stable brain metastases for>=1 month after treatment; 8. Good function of major organs: a) neutrophil count (ANC) >= 1.5 × 109/L; b) platelet count (PLT) >= 100×109/L; c) hemoglobin (Hb) >= 90 g/L; d) serum creatinine =50mL/min(creatinine clearance using Chockcroft-Gault formula); e) Total bilirubin (BIL) <=1.5 times upper limit of normal value (ULN); f) aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) levels <= 2.5 times the upper limit of normal value (ULN), or 5 times the upper limit of normal value (ULN) if combined with liver metastasis; g) international normalized ratio (INR) <= 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) <=1.5 times ULN; 9. Study participants of childbearing potential had to have had a negative serum pregnancy test within 72 hours before the first dose, were not lactating, and study participants and their partners were required to use effective contraception during the trial and for 6 months after the last dose of the trial drug. 10. I am willing and able to follow the planned visits, study treatments, laboratory tests, and other trial procedures if I have consented and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Known allergy to irinotecan hydrochloride liposome injection (II) and eboxizumab or drug excipients 2.History of severe active autoimmune disease 3.Participated in other drug studies within 4 weeks before enrollment 4.Imaging during the screening period showed that the tumor surrounded important blood vessels or had significant necrosis and voids, and the investigators determined that entering the study would cause bleeding risk 5.History of major illness within 1 year before the first medication 6.History of esophageal and gastric varices, severe ulcers, unhealed wounds, abdominal fistula, intraperitoneal abscess, or acute gastrointestinal bleeding within 6 months prior to initial administration 7.History of surgery or severe trauma within 4 weeks prior to initial dosing 8.Evidence and history of severe bleeding tendency; 9.Participants who had received or planned to receive a live vaccine within 4 weeks prior to the first study treatment 10.Patients with other cancer in 3 years,exceptions are adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix 11.History of alcohol abuse, psychotropic substance abuse or drug abuse. Other conditions considered unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate, DCR;Overall survival, OS;AE/SAE; | — |
Countries
China
Contacts
Public ContactWei Zheng/Zhaoxia Dai
Shengjing Hospital of China Medical University/The Second Hospital of Dalian Medical University
Outcome results
None listed