Clinical trial NCT06749691: Liposomal Irinotecan and Apatinib in ES-SCLC
Official title: Study of Liposomal Irinotecan Combined with Apatinib in the Treatment of Extensive Stage Small Cell Lung Cancer After First-line Progression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Small Cell Lung Cancer Extensive Stage
Keywords: Small Cell Lung Cancer
Liposomal Irinotecan
Apatinib
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to observe the efficacy and safety of liposomal irinotecan combined with apatinib in the treatment of extensive stage small cell lung cancer progressed from first-line regimen.

Detailed description: Small cell lung cancer is a highly invasive neuroendocrine tumor characterized by high malignancy and rapid proliferation. Although most patients with extensive SCLC are sensitive to first-line treatments such as etoposide combined with platinum and immunotherapy, most patients experience disease progression again after first-line treatment. Therefore, extending the survival time of patients and improving their quality of life have become key issues in the second-line treatment of SCLC. The current guidelines for second-line treatment of SCLC recommend monotherapy, including topotecan, irinotecan, etc. However, the available options have poor efficacy and are prone to drug resistance. Irinotecan liposomes improve drug stability and prolong circulation time through liposome encapsulation, and target tumor tissues through high permeability and long retention effects, with the expected effect of reducing toxicity and increasing efficacy. Apatinib is a small molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptors to achieve anti angiogenic and anti-tumor effects. It has been proven to have positive therapeutic effects in multiple types of cancer, including SCLC. At present, the combination mode of chemotherapy and anti-angiogenic drugs has been explored in various tumors, and the results show that this mode has drug synergistic effects, which can significantly improve the efficacy of anti-tumor treatment. Therefore, exploring the efficacy, safety, and mechanism of liposomal irinotecan combined with apatinib is of great clinical and theoretical significance for the refractory tumor population of extensive stage small cell lung cancer with first-line treatment progress.

Eligibility criteria: Inclusion Criteria:

1. Age range of 18-75 years;
2. Expected survival period ≥ 12 weeks;
3. At least one measurable lesion (according to RECIST V 1.1);
4. For patients who have failed first-line or second-line treatment.

Exclusion Criteria:

1. Have received any systemic treatment targeting VEGF or VEGFR in the past, such as treatment with anti angiogenic drugs such as ranibizumab, fipronib, apatinib, anlotinib, lenvatinib, sunitinib, sorafenib.
2. Active or uncontrolled severe infection (CTCAE 5.0 ≥ 2) and/or antibiotic treatment within 2 weeks prior to enrollment;
3. There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
4. Those deemed unsuitable for inclusion by doctors;

Primary outcomes:
measure: Progression-Free-Survival rate at 6 months
timeFrame: From enrollment at 6 months
Secondary outcomes:
measure: ORR
timeFrame: From enrollment to the end of treatment at 6-8 weeks
measure: mPFS
timeFrame: From enrollment to the end of treatment at 6-8 weeks
measure: mOS
timeFrame: From enrollment to the end of life at 3 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: