Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer
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 carb
| Condition(s) | Small Cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 s |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Tang-Du Hospital |
| Locations | Xi'an, Shannxi, China |
| Start date | 2024-03-15 |
| NCT ID | NCT06467786 |
| Official listing | https://clinicaltrials.gov/study/NCT06467786 |